Chief Science Officer and Vice President, Clinical Research 6
Richard Fogel, MD, FACC, FHRS
Executive Vice President and Chief Clinical Officer, Ascension 8
ACRI Leadership information 9
About ACRI 10
ACRI research vision 11
Publications 12
Nursing research 14
Clinical trials 16
Data science and analytics 17
ON THE COVER: Peter Monteleone, MD, Interventional cardiologist, Ascension Seton Medical Center consults with a patient.
Investigator profiles:
Mohamad Fakih 18
Daniel Gibson 19
Peter Monteleone 20
Lewis Jacobson 21
Maria Mupanomunda 22
Mitesh Patel 23
Cynthia LaFond 24
Ameila Drennan 25
Service line spotlights: Oncology 26
Cardiology 28 Neuro 30
Advancing our Mission 32
About Ascension
Ascension is a faith-based healthcare organization that delivers personalized, compassionate care to all, especially to those who are poor and vulnerable.
In FY23, Ascension provided $2.2 billion for care of persons living in poverty and community benefit. Our Mission-driven work is carried out through a number of services and subsidiaries dedicated to providing healthcare services and delivery to support personalized care.
THE CORE OF ALL WE DO
Mission
Rooted in the loving ministry of Jesus as healer, we commit ourselves to serving all persons with special attention to those who are poor and vulnerable. Our Catholic health ministry is dedicated to spiritually centered, holistic care which sustains and improves the health of individuals and communities. We are advocates for a compassionate and just society through our actions and our words.
Vision
We envision a strong, vibrant Catholic health ministry in the United States which will lead to the transformation of healthcare. We will ensure service that is committed to health and well-being for our communities and that responds to the needs of individuals throughout the life cycle. We will expand the role of the laity, in both leadership and sponsorship, to ensure a Catholic health ministry of the future.
Values
Service of the poor
Generosity of spirit, especially for persons most in need
Reverence
Respect and compassion for the dignity and diversity of life
TOTAL NUMBER OF publications that featured Ascension research IN THE LAST YEAR TODAY, MORE THAN 5,540 adults and children are enrolled in clinical trials throughout 12 MINISTRY MARKETS.
A MESSAGE FROM
Frederick Masoudi, MD, MSPH, Chief Science Officer and Vice President, Clinical Research
We are pleased to introduce the inaugural issue of the Ascension Clinical Research Institute (ACRI) annual report. ACRI continues to grow and develop; in this year’s report, you will find stories that share how we are building a system-wide research enterprise pursuing discoveries that change the way we prevent, diagnose and treat individuals with a special commitment to the poor and vulnerable. It is through discovery, continuous improvement and care transformation that we can advance the health and wellness of our patients and communities.
This annual report will showcase evidence of a bright future for the individuals and communities we serve, providing a deeper understanding of our work and why we do it. As a research community , we can strengthen our commitment to the most vulnerable patient populations by focusing our Ministry for greater impact, delivering time-tested and proven interventions to help patients thrive.
We are especially grateful for the work of our investigators, staff, and our research volunteers. None of our success would be possible without the support and leadership of our teams.
— Dr. Masoudi
MSPH, Chief Science Officer and Vice President, Clinical Research and Analytics
Frederick Masoudi, MD,
A MESSAGE FROM Richard Fogel, MD, FACC, FHRS,
Executive Vice President and Chief Clinical Officer
At Ascension, our patients are at the center of all we do. In order for us to meet our patients’ needs tomorrow, we must invest in advancing medicine today. Clinical research is an integral part of this work.
Under the direction of Dr. Fred Masoudi, we have created a robust clinical research infrastructure that spans our care footprint. We are connecting investigators across the country and supporting them as they provide the highest level of care to those we serve.
Through this national approach, we have had the opportunity to foster collaboration among our key clinical services lines. These synergies have strengthened our continuation of providing the latest evidence based care, while delivering new therapies and treatments. Consistent with our Mission, service to the poor and vulnerable is a central focus of our research program. This annual report is a reflection of this great teamwork and the incredible impact our clinical research teams have made day in and day out.
Our progress is a testament to the commitment of our investigators and research teams to our Mission. Their mission-driven work has led to enhanced outcomes for our patients. I continue to be inspired by all they do, and I hope this report leaves you inspired too.
— Dr. Fogel
About ACRI
ACRI LEADERSHIP
Frederick Masoudi, MD, MSPH, MACC, FAHA
Chief Science Officer and Vice President, Clinical Research and Analytics
Dr. Masoudi joined Ascension in 2021. He was previously a professor with tenure in the Department of Medicine at the University of Colorado Anschutz Medical Campus and Chief Scientific Advisor of the American College of Cardiology’s national registry programs (NCDR). He is an internationally recognized clinical scientist who has spent his career dedicated to cardiovascular care in practice, research, and education. He has co-authored over 375 peer-reviewed articles and contributed to national practice guidelines, scientific statements and policy documents.
Ryan Leslie, PhD
Associate Vice President, Research
Dr. Leslie is Associate Vice President of Research for Ascension and is the business and administrative leader for the Ascension Clinical Research Institute. Prior to his national research leadership role, Ryan was a member of the executive leadership team of Ascension Texas, where his responsibilities included analytics, research, graduate medical education (GME), and the development and support of collaborative data, research, and analytics capabilities for Ascension’s partnership with The Dell Medical School at the University of Texas at Austin. Ryan holds three degrees from UT-Austin, including a BBA in management information systems and an MS and PhD in health economics and outcomes research.
Tina Noonan
Senior Director of Human Research Protection
Tina Noonan is Senior Director of Human Research Protection for Ascension. Prior to this role, she spent ten years as the Executive Director for Research for Ascension Indiana. Tina is also a member of Ascension Clinical Research Institute’s (ACRI) Research Advisory Council, where she functions as the subject matter expert for Human Research Protections and IRB operations. She has more than 30 years of experience in the administration regulatory compliance oversight of medical research, spanning basic science, translational, and clinical research. She holds an MBA in Finance, is certified in Healthcare Research Compliance (CHRC) through the Healthcare Compliance Association (HCCA) and is a Certified IRB Professional (CIP).
About ACRI
Our vision:
In collaboration with partners and in alignment with our clinical programs, the Ascension Clinical Research Institute (ACRI) is committed to equitably advancing the health and wellness of the patients and communities we serve through discovery, continuous improvement, and care transformation.
Our investigators participate in clinical trials, implementation studies, and health services research supported by government, foundations, and industry sponsors. Clinical research is fundamental to improving care and developing new treatments.
Clinicians across Ascension conduct hundreds of research studies on new treatments and care strategies. In October 2022, Ascension formed a single Institutional Review Board (IRB) with regional panels and an office focused on streamlining minimal risk studies. Through a standardized IRB and Clinical Trials Management Systems, ACRI is optimizing research processes, billing and compliance standards. ACRI’s structure also allows clinicians to share best practices and encourage research alignment.
ACRI provides clinical research support and oversight to all sites engaged in research, including:
• A multi-site clinical trials coordination center
• A single, Ascension-wide Institutional Review Board
• Centralized research business and legal offices
• Therapeutic-area clinical research forums
• Clinical data analytics
In addition, ACRI seeks to foster partnerships with all types of partners including federal, state,commercial, and non-profit organizations. In addition, the program focuses on creating and fostering new partner relationships to amplify the capacity and reach of research in Ascension.
ACRI RESEARCH VISION
The five goals for research at Ascension will guide the enterprise toward fulfilling its vision for research.
Enhance patient outcomes
All of our research is intended to develop new evidence to improve the care and outcomes of the individuals who entrust us with their care.
Community engagement
Robust participation in research across the spectrum of socioeconomic status and inclusive of all races and ethnicities requires trust and connection with the communities we serve.
5
1
Align
4
3
2
Research partnerships
Our objective is to develop strategic and lasting relationships with research sponsors and our academic partners.
and optimize
Our research is embedded within care delivery and serves the clinical objectives of our programs. Research is not an end, but a means to enhance the care we provide.
Engage clinicians
Research provides an opportunity for our clinicians to diversify their professional lives and contribute to knowledge generation.
Publications
Our investigators’ research has been featured in prominent journals. Here are several examples of where our research was spotlighted in FY24.
Journal of Clinical Oncology
Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles.
2024 Mar 5
Authors:
Sarraj A et al (Warach, Steven)
Selection of Germline Genetic Testing Panels in Patients With Cancer: ASCO Guideline.
2024 May 17
Authors:
Tung N et al (Cohen, Stephanie)
Journal of the American College of Cardiology Transcatheter
Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation: COAPT Post-Approval Study.
2023 Sep 26
Authors: Goel K et al (Morse, Michael; Hermiller, James)
The Lancet
Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial.
2024 Feb 24
Authors: Sarraj A et al (Gibson, Daniel; Warach, Steven)
Circulation
Mechanical
Thrombectomy Global Access For Stroke (MT-GLASS): A Mission Thrombectomy (MT-2020 Plus) Study. 2023 Apr 18
Authors:
Asif KS et al (Asif, Kaiz)
Science Advances
Sex in cardiovascular disease: Why this biological variable should be considered in in vitro models.
2024 May 10
Authors: McClain AK et al (Monteleone, Pete)
Journal of Medical Internet Research
Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial. 2024 May 17
Authors: Manz CR et al (Patel, Mitesh)
Clinical Infectious Diseases
Excellence in Antibiotic Stewardship: A mixed methods study comparing High, Medium, and Low Performing Hospitals. 2023 Dec 6
Authors: Vaughn VM et al (Johnson, Leonard)
Journal of the American College of Cardiology: Heart Failure
Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device Among Women and Men. 2023 Dec
Authors: Ramu B et al (Ravichandran, Ashwin)
Journal of Allergy and Clinical Immunology
Lower socioeconomic status may help explain racial disparities in asthma and atopic dermatitis prevalence: A mediation analysis.
2024 Apr
Authors:
Croce EA et al (Croce, Emily; Matsui, Elizabeth)
The Journal of Pediatrics
Financing Policy Considerations From Texas to Optimize Care for Children With Medical Complexity. 2024 Jan 1
Authors: Kirsch L et al (Sharp, Kendall; Alexander, Mari-Ann; Santa, Sherry)
Psychological Medicine
Sex-dependent differences in vulnerability to early risk factors for posttraumatic stress disorder: results from the AURORA study.
2024 May 22
Authors: Haering S et al (Pearson, Claire)
Microbiology
Spectrum
Eravacycline, the first four years: health outcomes and tolerability data for 19 hospitals in 5 U.S. regions from 2018 to 2022.
2024 Jan 11
Authors: Kunz Coyne AJ et al (Cosimi, Reese)
Genome Medicine
Molecular-guided therapy for the treatment of patients with relapsed and refractory childhood cancers: a Beat
Childhood Cancer Research Consortium trial.
2024 Feb 12
Authors: Sholler GLS et al (Harrod, Virginia)
Pharmacology & Therapeutics
Mechanistic and therapeutic relationships of traumatic brain injury and γ-amino-butyric acid (GABA).
2024 Apr
Authors: Witkin JM et al (Witkin, Jeffrey; Cerne, Rok; Smith, Jodi)
European Journal of Heart Failure
Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1-year results.
2024 Apr 12
Authors: Urey MA et al (Chaudhry, Sunit-Preet; Hermiller, James)
Molecular Psychiatry
Structural inequities contribute to racial/ ethnic differences in neurophysiological tone, but not threat reactivity, after trauma exposure. 2023 Jul
Authors: Harnett NG et al (Pearson, Claire)
JAMA
Nursing research
Research plays an essential role in nursing by generating new knowledge that informs patient care and the healthcare systems in which care is delivered. Nurses are leading the way in generating and disseminating new, clinically-meaningful knowledge that supports standardized care delivery and optimizes patient care outcomes across our ministry.
The Ascension nursing community is committed to advancing nursing practice through the conduct of research. Our aim is to conduct meaningful research with actionable outcomes/implications for patient care - ultimately creating a continuously learning healthcare system, where research questions are generated from practice needs and findings from our own research guides decision making for practice and operations.
THE BIG PICTURE:
By equipping nurses to engage in and lead research, the Ascension National Nurse Research Affinity Group is creating a unified environment of discovery across Ascension. Through their research, these nurses live out our Vision of transforming healthcare to support health and well-being for our patients and communities.
FY24 Fast Facts
116 active research studies with nurses as PIs or Co-IS
$1M in workforce funding being implemented
OUR NURSING RESEARCH TEAM’S INTERNATIONAL AND NATIONAL EXTERNAL IMPACT
18 regional, national and international professional presentations featured our Nursing Research team boards, committees, research groups feature representation from our Nursing Research team 7+
$800K of perspective research funding for strategic initiatives
30 peer-reviewed publications with Ascension nurse authors including those led or supported by nurse scientists.
106 learners who benefited from didactic and real-time nursing research initiatives including manuscript development, abstracts, critical appraisal
FY24 operational, practice-based and financial impact of our Nursing Research team
$3.4M* in cost avoidance includes conservative estimate for cost of fall.
$13.8M is estimate for 2023 cost data recently published
30 evidence summaries
Internal and external evidence that informed decision-making.
SAFETY
17 Fall prevention and post-fall management
2 CAUTI
1 Hyper/ hypoglycemia
SAFETY/EQUITY
5 Pressure injury (PI) prevention
WORKFORCE
5 Workforce retention
24 studies
Addressing key research gaps in patient safety, equity, and workforce well-being.
Examples:
SAFETY
Predictive performance of fall assessment tools
Predictors of perioperative and medical device related PIs
SAFETY/EQUITY
Association between skin tone and PI stage
WORKFORCE
New graduate nurse occupationalself-efficacy and patient safety actions
15 practice changes led
Nurse scientists collaboratively designed/ led change initiatives with the knowledge gained. Examples:
SAFETY
Standardization of system’s fall assessment tools and post fall debrief process
Fall TIPS program
Evidence-based fall, PI, CAUTI prevention bundles
SAFETY/EQUITY
Skin tone assessment included into pressure injury prevalence
WORKFORCE
Student nurse apprenticeship
Data science and analytics Clinical trials
1,120
TOTAL NUMBER OF clinical trials open in FY24
TODAY, MORE THAN 5,540 adults and children are enrolled in clinical trials throughout 12 MINISTRY MARKETS.
Ascension hospitals have long conducted clinical trials in a wide range of clinical areas. Recently, with the formation of ACRI, Ascension has centralized some research administrative functions and has adopted more consistent policies and procedures to support increasingly effective and efficient research activities. This evolution has facilitated Ascension’s participation in clinical trials as a network, with a single point of contact for sponsors and the creation of organizationwide research communities that can share best practices around trial enrollment. Key changes that support the Ascension clinical trials network include
Cardiology and oncology are the predominant areas of study. Other areas of interest include cystic fibrosis, genetics, multiple sclerosis, Alzheimer’s disease, stroke and allergy. Additionally, there are numerous ongoing clinical trials on COVID-19. IN FY24, ACRI LAUNCHED ELEVEN
• A single Ascension Human Research Protection Program, including a single Institutional Review Board
• A central legal office to process non-disclosure agreements, clinical trial agreements, and other legal documents
• A central finance and accounting office
• Enterprise-wide technology platforms, including a Clinical Trials Management System and an electronic IRB system
*Individuals with any clinical trial visit at Ascension in FY24
LEADS
Kevin Willmann, Vice President, ADSI Clinical Analytics TEAM
Collin Miller, Manager, Data Analytics
The clinical analytics team in the Ascension Data Sciences Institute (ADSI) works closely with ACRI and supports clinical service lines in performing data analytic research focused on improving the quality of care and outcomes of the patients we serve. The team mobilizes Ascension’s clinical data from several sources to generate clinically meaningful insights to advance care.
Our multidisciplinary “Recognize and Rescue” effort includes a bundle of elements to prevent events and to promptly care for patients that experience a deterioration in their condition in the hospital. Our intervention was associated with >20% improvement in mortality, outperforming our peers by 13%.
— Dr. Fakih
Click here to read Dr. Fakih’s full interview
Chair
As a Catholic health system, we now have the expertise and technological resources to perform “miracles” by curing stroke and restoring function to patients on a daily basis. Our research allows increasing numbers of patients to have access to these therapies.
Gibson “ “
—
Click here to read Dr. Gibson’s full interview
Daniel Gibson, MD, Neuroscience Service Line
Dr.
INVESTIGATOR PROFILE Q&A
Peter Monteleone, MD, Interventional cardiologist, Ascension Seton Medical Center and Director of Cardiovascular Research
Clinical trials provide access for our patients to the most revolutionary cardiovascular therapies in real time — therapies our patients often do not have the luxury of waiting years to obtain. Our advances therapeutic safety and advance clinical decision making for the generations to come.
“
— Dr. Monteleone
Click here to read Dr. Monteleone’s full interview
Lewis Jacobson, MD, Trauma Medical Director, Director of Surgical Critical Care and Chair of Surgery, Ascension St. Vincent Indianapolis
“ “
Research helps to position the organization at the cutting edge of new discoveries and developments in the field of trauma and offers us the opportunity to deliver the best care for our patients at the earliest possible time following new advances.
— Dr. Jacobson
Click here to read Dr. Jcobson’s full interview
INVESTIGATOR PROFILE Q&A
Maria Mupanomunda, MD, PhD, MBA, Director, Quality, Ascension
In my role, research is a powerful tool to drive systemic change. It enables me to analyze data, identify gaps and to seek evidence-based solutions that are tailored to the diverse needs of the populations we serve.
“
— Dr. Mupanomunda
Click here to read Dr. Mupanomunda’s full interview
Patel, MD, Vice President and Chief Clinical Transformation Officer, Ascension
My research helps to advance Ascension’s Mission to serve vulnerable populations and reduce disparities of care by implementing and testing new and lower friction approaches to prompt scheduling visits and closing care gaps.
— Dr. Patel
Click here to read Dr. Patel’s full interview
Mitesh
INVESTIGATOR PROFILE Q&A
My research at Ascension focuses on our three strategic priorities for nursing: patient safety, health equity and nurse well-being...I love that this research is pragmatic and that the findings can be applied into practice almost instantaneously.
“
— Amelia Drennan “ “
I had no idea there was a role in our ministry for nurses to be a part of research and after seeing this very sick patient’s trajectory change due to the research, I knew I wanted to be a part of that.
Click here to read Dr. LaFond’s full interview
Click here to read Amelia Drennan’s full interview
Cynthia LaFond, PhD, RN, CCRN-K Senior Director, Nursing Research
— Dr. LaFond
Ameila Drennan, MBA, BSN, RN, Director, Saint Thomas Research Institute
Service line spotlight
ONCOLOGY
Collaboration to fuel new oncology research
Ascension aims to improve cancer care through its community of investigators
Across Ascension, oncology researchers are coming together to position the organization as a national leader in cancer care.
According to the Centers of Disease Control and Prevention (CDC)’s latest data, more than 1.6 million people are diagnosed with cancer, and nearly 600,000 die from it in the U.S. each year. It’s also the nation’s second leading cause of death. New research to prevent, detect and treat cancer is imperative to reversing these statistics.
ACRI and the Ascension Data Science Institute (ADSI) have partnered with Ascension’s Oncology Service Line to develop a national research strategy specifically aimed at advancing cancer care.
“By aligning our research efforts, we have a tremendous opportunity to move the needle on cancer care across our System and even nationally,” said Richard Fogel, MD, FACC, FHRS, Executive Vice President and Chief Clinical Officer. “And, due to our size and expertise, this coordinated approach can make Ascension an attractive research partner for trials and large studies.”
An incubator for trials research
For several years, Ascension has been laying the groundwork to become an incubator for cancer research.
“We are one of the top enrollees for pediatric oncology clinical trials when our Ministry Markets efforts are combined,” said Thomas Aloia, MD, MHCM, FACS, FACHE, Senior Vice President and Chief Medical Officer.
“Currently, we have four sites participating in research with the Children’s Oncology Group (COG).” The COG is a National Cancer Institute (NCI) supported organization that is part of the National Clinical Trials Network and is one of the world’s largest, cooperative children’s cancer research entities.
Ascension and affiliated practices also combine to be one of the top research sites enrolling in the Gynecologic Oncology Group (GOG) creates the opportunity to participate in the latest clinical trials of novel therapies for gynecologic malignancies such as ovarian and cervical cancers.
“Throughout Ascension, our clinicians are engaging in innovative oncology research,” said Dr. Aloia. “Much of this research focuses on identifying potential opportunities to improve outcomes through precision medicine, which takes into account tumor genetics, patient lifestyle and environmental factors to determine best treatment options. As we look to the future, we are excited to expand upon these efforts to personalize cancer care.”
Bringing value to those we serve
Ascension’s participation in medical oncology clinical trials also has the opportunity to bring significant value to patients.
“Research plays an integral role in improving the care we deliver to our patients,” said Dr. Masoudi.
“By offering clinical trials as an option, we present our patients with a unique opportunity to participate in studies of technologies and treatments that may not yet be widely available. Patients may also feel like they are helping others by participating and contributing to science.”
“As we continue to build our clinical research program, we look forward to working alongside our Oncology Service Line colleagues to align Ascension’s research efforts, identify new partnership opportunities, and transform cancer care as we know it today,” added Dr. Masoudi.
Carole Miller, MD Interim Chief Medical Officer, Cancer Institute Director, Ascension Saint Agnes Hospital
125th patient enrolls in Lighthouse Study
Earlier this spring, the Ascension Saint Agnes team celebrated enrolling their 125th patient in the Lighthouse Study, which focuses on individuals who are scheduled to undergo a screening CT scan for lung cancer. The study involves answering a few health questions and having blood drawn prior to the CT scan. Patients agree to have blood drawn prior to their CT scans for 3 years.
The ministry market enrolled their first patient in the study in June 2023. The study is open worldwide with over 20,000 patients enrolled in the Lung Cancer Screening Cohort. The purpose of this research study is to collect blood samples and medical information to help in the development of a blood test that can screen for many cancers from a single blood draw. This is an experimental test which is still under development. The goal of this blood test is to help doctors find cancers early, potentially at a time when tumors are still small. Researchers will look at markers in the blood that show up when cancer is just developing. These findings from the blood along with medical history and results from the routine cancer screening done during the 3 year study will be used to develop better cancer screening tools from blood tests.
Service line spotlight
CARDIOLOGY
Ascension’s Cardiovascular Service Line is currently conducting more than 300 studies. This important area of research continues to be a focus area for ACRI. In turn, Ascension recently launched a new approach to cardiovascular research, which focuses on two pillars: clinical trials performance and investigator-initiated research.
“Our first pillar, clinical trial performance, focuses on attracting strong research partners so that we can make sure that the newest and most advanced medical technologies are available to our patients,” said Peter Monteleone, MD, Director, Ascension Texas Cardiovascular Research and Ascension Seton Cardiac Catheterization Laboratory. Our second pillar, investigator-initiated research, focuses on creating a strong infrastructure that supports our clinician-led research initiatives. By implementing this strategy, we have a tremendous opportunity to work together and collect valuable data to transform cardiovascular care at Ascension and beyond.”
Ascension’s cardiovascular teams are putting these strategies to work. Prior to the COVID-19 pandemic, several clinicians collaborated across markets to study the implementation
of a national same-day discharge initiative for patients who undergo percutaneous coronary intervention (PCI), a non-surgical procedure that uses a catheter to place a stent to open an occluded blood vessel within the heart.
Collectively, teams across the country studied this program and demonstrated that a Systemwide same-day discharge program could be developed and executed safely and effectively when applicable.
“This finding is an excellent example of how our collaborative research can advance high quality care,” Dr. Monteleone said. “With a national same-day discharge protocol both in place and proven effective through our analysis, it not only makes our patients happier, but it gives us the opportunity to safely shift resources to other patients in need. This was critical during the pandemic when our hospitals have been under unprecedented strain.”
“With Ascension’s size, we have a tremendous opportunity to shape heart health through research,” Dr. Masoudi said. “Our clinicians are redefining new therapies, treatments, screening guidance and more through their discoveries, ultimately improving care for those we serve.”
Ascension’s clinical trials network in action
Nine Ascension Ministry Markets across 11 sites of care are participating in a trio of phase III clinical trials to study the efficacy and safety of a new class of anticoagulants, or blood thinners, in three different conditions: atrial fibrillation, stroke and acute coronary syndrome.
The study will investigate an oral factor XIa inhibitor called milvexian, and determine if it could be a potential substitute for existing anticoagulants for atrial fibrillation, or an additional therapy for patients at high risk for strokes and acute coronary syndromes. Early data suggests that it may provide the same protective effects as current anticoagulants with a better safety profile.
Each condition with the drug will be studied and led by:
• Atrial fibrillation: Robert (Drew) Pickett, MD, Ascension Tennessee;
• Stroke: Errol Gordon, MD, Ascension St. John Medical Center, Tulsa, Oklahoma
Dr. Monteleone huddles with his team, from left, Angel Mkumbo, Teonna Piphus and Katherine Lentz. Our participation in these trials illustrates Ascension’s capacity to build a robust national trials network.
— Dr. Masoudi. “ “
Service line spotlight
NEURO
Ascension is a national leader in stroke research, with several sites and investigators contributing to several landmark clinical trials in pharmacological and interventional therapies for acute cerebrovascular events.
Steven Warach, MD, PhD, FAHA, Executive Director, Seton Dell Medical School Stroke Institute and Stroke Medical Director, Ascension Texas, has noted that “over the last several years, the Stroke Service Line across Ascension’s ministries has come together to standardize best practices for stroke care, introduce quality improvement initiatives, and publish retrospective analyses from its centralized clinical database,” Dr. Warach said. “Now, with the standardization of Ascension research processes, the Ascension Stroke Team is positioned to expand its research portfolio to multicenter clinical trials and influence improvements in stroke outcomes.”
New research can help Ascension stroke patients live longer, healthier lives
Ascension investigators, Daniel Gibson, MD, and Steven Warach, MD, PhD, believe in expanding stroke care to ensure all patients are appropriately screened, triaged and have access to evidence-based treatment options. Their dedication to Ascension’s Mission is what led them, along with an international team of top stroke researchers, to take a closer look at the long-term benefits of surgical intervention to remove blood clots (thrombectomy) in patients suffering from ischemic stroke.
The study, published in the Lancet, found markedly better functional outcomes in patients who experience large strokes treated with thrombectomy compared to those receiving medical care alone at 1-year follow-up.
“Across Ascension, a principal focus of our research efforts is to identify and develop new targeted interventions for our patients,” said Frederick Masoudi, MD, MSPH, Chief Science Officer and Vice President, Clinical Research and Analytics.
“Drs. Gibson and Warach’s contributions to this study will help advance stroke treatment not only for those we serve, but nationwide.”
This new research supports the safety of endovascular thrombectomy in patients who may previously have had limited treatment options. Ascension’s innovative deployment of these findings and early adoption of novel therapies will reduce rates of death and disability and help patients live longer, healthier lives.
Ascension participated in groundbreaking study that advances treatment of acute ischemic stroke
Three Ascension hospitals were among 31 that participated in a groundbreaking global study published in the New England Journal of Medicine. The study, led by Amrou Sarraj, MD, and sponsored by University Hospitals
Cleveland Medical Center in collaboration with Stryker Neurovascular and The University of Texas Health Science Center – Houston, examined patient selection criteria for thrombectomy procedures following acute ischemic stroke. Ascension was one of the largest multistate health systems to take part in the study, with participating sites in Wisconsin, Texas and Indiana.
An ischemic stroke is the most common type of stroke, occurring when a blood clot blocks or narrows an artery leading to the brain. Thrombectomy is a procedure in which highly specialized physicians use devices to remove the blood clot from the obstructed artery and restore blood flow to the brain.
The study followed 352 patients across six countries with the most severe type of strokes; participants were randomly assigned to receive either mechanical thrombectomy or usual stroke care. The study found that those receiving thrombectomy had significantly better clinical outcomes, including functional independence, after three months. Rates of death did not differ between the groups, though in some cases thrombectomy was associated with vascular complications.
Ascension Research: Advancing our Mission
Ascension has undertaken a deliberate effort to address long standing gaps in representation in its approach to clinical trials. We are proud that our trials closely mirror the demographics of our patient population—a significant achievement considering historical underrepresentation and understandable feelings of mistrust. Ascension leverages our unified clinical trials management system to gain detailed insights into participant demographics across our organization. This allows us to identify areas needing improvement and implement targeted measures to enhance diversity.
Diversity in clinical trials is essential for several reasons. It ensures that treatments and therapies are effective across diverse populations, as individuals from various ethnic and racial backgrounds may respond differently to medications. Including diverse participants also leads to more generalizable results that benefit a wider range of people. Furthermore, diversity fosters trust in medical research among marginalized communities, encouraging greater engagement and participation.
Through this focus, we can advance healthcare and uphold our Mission of providing equitable care to all. We are dedicated to sustaining and expanding these efforts by collaborating closely with sponsors to develop innovative approaches that further boost trial enrollment among diverse populations including addressing logistical barriers and enhancing trust within these communities.
Ascension St. John Clinical Research Institute honored with inaugural Global Site Excellence in Diversity Award
The Ascension St. John Clinical Research Institute in Tulsa, Oklahoma, was honored as the inaugural recipient of the Society for Clinical Research Sites’ Global Site Excellence in Diversity Award. The award recognizes and celebrates the outstanding efforts of clinical research sites worldwide in advancing diversity, equity and inclusion in clinical trials.
In 2019, the Ascension St. John research department implemented a community outreach plan called the BRIDGE (Bringing Diversity Together) framework with the hopes of reshaping not only the department, but the community’s future. The framework focuses on increasing the diversity of those enrolled in clinical trials and reaching out to the
communities where these individuals live. The BRIDGE framework taps into the diverse needs of various demographics of the Tulsa community to help Ascension St. John’s research team cultivate trust and overcome obstacles to trial participation.
Becker’s Hospital Review: Ascension’s science chief on the mission-driven work to increase clinical trial diversity
Recognizing a lack of diversity in their clinical trials and research, St. Louis-based Ascension set out to improve in this area, and has made strides that have recently received recognition.
This “mission-aligned” work has been a focus for Frederick Masoudi, MD, chief science officer at the health system, who began his role in 2021.
Dr. Masoudi told Becker’s he’s specifically been involved in developing a national structure to help enable research across Ascension, which includes improving the representativeness of populations that are enrolled in clinical trials.
“Ascension’s mission is to care for the poor and vulnerable,” he said. “This work is entirely aligned with our long-standing mission.”
The work began by measuring how the health system was doing in this area. Ascension adopted an enterprise-wide clinical trials management system, which provided information about populations that were enrolling in clinical trials across the organization.
“I was happy to see that as we’ve aggregated those data, that the populations we enroll in clinical trials with respect to race and ethnicity very closely mirror the population for which we care for, which is a good place to start,” said Dr. Masoudi.
One example he cited was a clinical trial that supported colleagues within Ascension DePaul Services of New Orleans. The trial occurred at a clinic that serves a predominantly ethnic minority population and centered around a cognitive behavioral therapy app to improve diabetes control.
“They knocked it out of the park in enrolling individuals at DePaul,” Dr. Masoudi said. “They have a very motivated and capable team. They have long worked in the community and have built trust there, which is a key component to engaging individuals in trials. As a result, the population enrolled in the clinical trial was completely transformed with respect to race and ethnicity.”
— Dr. Masoudi “ “
Ascension’s mission is to care for the poor and vulnerable. This work is entirely aligned with our long-standing mission.
Members of the BRIDGE team from Ascension St. John Clinical Research Institute in Tulsa, Oklahoma Click here to read the full article from Becker’s Hospital Review.
