The Icahn School of Medicine at Mount Sinai has received a $2 million grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to study which therapy is optimal for treating spontaneous coronary artery dissection (SCAD), a sudden tear in the wall of a heart artery that that supplies blood to the heart, which can reduce blood flow and cause an uncommon type of heart attack.
Mount Sinai will use the funding for a one-year feasibility phase of the United States portion of a major international clinical trial to determine whether aspirin alone or a more intensive combination of blood-thinning medications is better for treating this condition. Led by the Clinical Trial Center of Mount Sinai Fuster Heart Hospital and the Institute for Transformative Clinical Trials, the study aims to provide evidence that can inform future treatment recommendations for patients with SCAD worldwide and improve outcomes. Following a successful feasibility phase, Mount Sinai will receive approximately $14 million over seven years from NIH to launch a larger United States portion of the same clinical trial.
“Because SCAD disproportionately affects women, often at a relatively young age and without the traditional warning signs of heart disease, answering this question is particularly important. Our goal is to determine which treatment provides the best protection while exposing patients to the least unnecessary risk,” says Roxana Mehran, MD, Mount Sinai Professor in Cardiovascular Clinical Research and Outcomes, Icahn School of Medicine at Mount Sinai. Dr. Mehran is a Principal Investigator for the trial’s clinical coordinating center.
“SCAD is a very different disease from the type of heart attack we encounter most often, yet many of the treatments we use today have been adopted from studies conducted in other patient populations. This trial gives us an opportunity to generate the rigorous evidence that patients with SCAD and their physicians have been waiting for,” says Deepak L. Bhatt, MD, MPH, Director of Mount Sinai Fuster Heart Hospital and a Principal Investigator of the clinical coordinating center.
Roughly 80 to 95 percent of SCAD cases occur in women, most of whom are between 42 and 52 years old and may not have traditional cardiovascular disease risk factors such as high cholesterol or diabetes.
After a typical heart attack, patients are often treated with antiplatelet medications to make platelets in the blood less likely to stick together and form clots. Because SCAD is caused by a problem within the artery wall rather than cholesterol buildup, doctors do not have clear evidence about the best treatment. Many treatments currently used for these patients were developed for more common types of heart attack caused by cholesterol buildup. These treatments have not been adequately tested in a large, randomized trial specifically for SCAD. This study is designed to provide evidence directly relevant to these patients.
The new trial, known as SCAD-ALIGN, will compare a moderate antiplatelet strategy of aspirin alone for three months with a more intensive strategy of dual antiplatelet therapy for three months followed by nine months of single antiplatelet therapy. Researchers plan to enroll roughly 3,500 patients internationally (roughly 500 in the United States at 60 sites) and evaluate major cardiovascular outcomes, including cardiovascular death, myocardial infarction, recurrent SCAD, unplanned coronary revascularization, stroke, transient ischemic attack, and bleeding.
“SCAD is relatively uncommon, so no single center or country can easily enroll enough patients to answer this question reliably. This project brings together research networks and national funding organizations across multiple countries under one common study protocol,” says Alan Moskowitz, MD, Professor of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai and a Principal Investigator for the trial’s data coordinating center.
“We expect that this trial will represent a novel model of international academic collaboration and provide the first large-scale randomized evidence to help guide antiplatelet therapy in this patient population,” adds Annetine Gelijns, PhD, Chair of the Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai and a Principal Investigator for the data coordinating center.
“This coordinated approach is intended to generate robust evidence for an important clinical question that affects women disproportionately and for which large-scale industry-sponsored research has been limited,” says Emilia Bagiella, PhD, Director of the Center for Biostatistics in the Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai and a Principal Investigator for the data coordinating center.
SCAD-ALIGN was endorsed by the Multinational Clinical Trials Initiative of the Global Cardiovascular Research Funders Forum (GCRFF). The global collaboration includes investigators and funding organizations from the United States, Germany, the United Kingdom, Canada, the Netherlands, Denmark, Sweden, Spain, Australia, New Zealand, and other participating countries, with additional participation from centers in South America.
About the Mount Sinai Health System
Mount Sinai Health System is one of the nation’s leading integrated academic health systems and one of the largest in the New York metropolitan area. Its comprehensive system includes seven hospitals, more than 400 outpatient practices, over 600 research and clinical laboratories, the Icahn School of Medicine at Mount Sinai, the Graduate School of Biomedical Sciences, and the Mount Sinai Phillips School of Nursing. Together, the Health System comprises approximately 48,000 employees, more than 9,000 physicians, and 8,600 nurses.
As a leading learning health system, Mount Sinai combines clinical expertise with scientific discovery to improve patient care while training the next generation of health care and biomedical leaders. The Health System provides care across every stage of life, from prenatal care through geriatrics, while advancing personalized medicine through artificial intelligence, data science, and biomedical research.
Mount Sinai is consistently recognized among the nation’s leading academic health systems for patient care, research, and education. The Mount Sinai Hospital is ranked No. 1 in New York by Newsweek and No. 5 on the magazine’s World’s Best Hospitals list. The Icahn School of Medicine at Mount Sinai ranks No. 11 among U.S. medical schools and No. 1 among freestanding medical schools for National Institutes of Health funding, reflecting the strength of its scientific enterprise and leadership in biomedical research.