Mount Sinai has received a $2 million grant from the National Heart, Lung, and Blood Institute to begin the U.S. feasibility phase of an international SCAD clinical trial. The study will compare treatment strategies for spontaneous coronary artery dissection, a heart condition that occurs predominantly in women.
The research addresses a significant evidence gap in SCAD care, where treatment approaches have largely been adapted from other forms of heart attack despite important differences in how the condition develops.
Key Takeaways
- Mount Sinai received a $2 million grant from the National Heart, Lung, and Blood Institute
- The funding supports a one-year U.S. feasibility phase of an international clinical trial
- Researchers will compare two antiplatelet treatment strategies for spontaneous coronary artery dissection
- About 80% to 95% of SCAD cases occur in women, Mount Sinai reports
- The international trial plans to enroll about 3,500 patients, including approximately 500 participants in the United States
Mount Sinai Receives $2 Million for SCAD Trial
The $2 million grant will support the U.S. feasibility phase of an international study examining treatment for spontaneous coronary artery dissection, commonly known as SCAD. Mount Sinai is leading the U.S. portion of the research.
SCAD occurs when a spontaneous tear or separation develops within the wall of a coronary artery. Blood can accumulate within the artery wall, narrowing or blocking blood flow and potentially causing a heart attack.
Unlike many heart attacks associated with atherosclerotic plaque buildup, SCAD begins within the artery wall. It can affect people who have few or none of the cardiovascular risk factors commonly associated with coronary artery disease.
Mount Sinai reports that roughly 80% to 95% of SCAD cases occur in women, with many affected women between ages 42 and 52. That age range overlaps with a period when other research has documented cardiovascular changes during perimenopause, although SCAD is a distinct condition and the new trial is focused specifically on its treatment.
The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, is funding the one-year feasibility phase. The initial work is intended to establish the foundation for a larger U.S. component of the international trial.
Clinical Trial Compares SCAD Treatment Strategies
The study will compare two antiplatelet approaches in patients with SCAD. One strategy uses aspirin alone, while the other involves more intensive antiplatelet therapy.
Antiplatelet medicines reduce the ability of platelets in the blood to stick together and form clots. They are commonly used after conventional heart attacks, but researchers do not yet have large-scale randomized evidence establishing the optimal antiplatelet strategy specifically for SCAD.
That distinction matters because SCAD differs from the cholesterol-related blockages responsible for many other heart attacks. The underlying problem involves the coronary artery wall rather than the same type of atherosclerotic plaque disruption seen in typical coronary artery disease.
As a result, treatment practices developed for more common forms of heart attack may not necessarily produce the same balance of benefits and risks in people with SCAD.
The international trial is designed to generate direct evidence by comparing patient outcomes under the two treatment strategies. Researchers will assess cardiovascular outcomes including heart attack, recurrent SCAD, stroke, bleeding and other major events.
The study does not assume that either approach is superior. Its purpose is to provide randomized evidence that can better inform future treatment decisions.
SCAD Disproportionately Affects Women
Women make up the large majority of patients diagnosed with SCAD. Mount Sinai estimates that approximately 80% to 95% of cases occur in women.
Many affected patients also differ from the population commonly associated with coronary artery disease. Women with SCAD may have few traditional cardiovascular risk factors such as high cholesterol or diabetes.
SCAD can narrow or block a coronary artery and cause a heart attack, making timely medical evaluation important when symptoms occur. Broader research into heart attack symptoms in women has highlighted the importance of recognizing cardiovascular events across female patient populations.
The new trial focuses specifically on what happens after SCAD is diagnosed. Researchers are examining how different antiplatelet strategies affect outcomes rather than testing a lifestyle-based prevention program.
The concentration of SCAD cases among women also makes the trial relevant to a broader effort to improve evidence for cardiovascular conditions that disproportionately affect female patients.
International Trial Plans to Enroll About 3,500 Patients
Researchers plan to enroll approximately 3,500 patients across the international clinical trial, including about 500 participants in the United States.
The U.S. component is expected to involve roughly 60 clinical sites. The larger international collaboration includes investigators and funding organizations across multiple countries, allowing researchers to study a condition that individual centers may encounter relatively infrequently.
That scale is particularly important for SCAD because its lower prevalence makes it difficult for a single hospital or research network to enroll enough patients for a large randomized trial.
The study will use a common research protocol across participating locations, allowing investigators to compare treatment outcomes across a much larger patient population.
Planned enrollment figures describe the intended scale of the broader study rather than the number of patients who have already entered the trial. The current NIH award supports the initial U.S. feasibility work that precedes the larger domestic study.
By combining research networks across countries, investigators aim to build a body of evidence large enough to address questions that smaller observational studies have been unable to resolve.
U.S. Feasibility Phase Sets Up Larger Study
The one-year U.S. feasibility phase is the first step toward a larger domestic component of the international clinical trial.
Mount Sinai will use the initial NIH funding to establish the U.S. research infrastructure and evaluate the feasibility of expanding enrollment across participating sites. A larger U.S. study would require additional funding.
The research centers on a practical clinical question: whether aspirin alone or a more intensive antiplatelet approach provides the appropriate treatment strategy for patients with SCAD.
Current practice has developed without a large randomized trial specifically testing these approaches in the SCAD population. The international study is designed to help close that evidence gap.
Researchers plan to evaluate a range of cardiovascular outcomes, including recurrent SCAD and bleeding, to understand the effects of each strategy rather than focusing on a single measure.
For a condition that disproportionately affects women and can occur without conventional coronary risk factors, the study represents a substantial effort to generate treatment evidence directly from patients with SCAD.
Frequently Asked Questions
What is spontaneous coronary artery dissection?
Spontaneous coronary artery dissection, or SCAD, occurs when a spontaneous tear or separation develops within the wall of a coronary artery. This can narrow or block blood flow and cause a heart attack.
What is the new SCAD clinical trial studying?
The trial will compare aspirin alone with a more intensive antiplatelet treatment strategy in patients diagnosed with SCAD. Researchers will evaluate cardiovascular and bleeding outcomes associated with the two approaches.
Why is SCAD closely associated with women’s heart health?
Mount Sinai reports that approximately 80% to 95% of SCAD cases occur in women, many of whom are between ages 42 and 52 and may have few traditional cardiovascular risk factors.
How many patients will participate in the SCAD trial?
Researchers plan to enroll approximately 3,500 patients internationally. About 500 participants are expected to join the U.S. portion of the trial across roughly 60 sites.
Who is funding the SCAD clinical trial?
The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, awarded Mount Sinai $2 million to support the one-year U.S. feasibility phase.
Disclaimer:
This article is for informational purposes only and does not constitute medical advice, diagnosis or treatment. Anyone experiencing symptoms of a heart attack or other medical emergency should seek immediate medical care. Questions about SCAD, medications or treatment options should be discussed with a qualified healthcare professional.
