Actively Recruiting
Imaging Coronary Microvascular Dysfunction (CMD) Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-16
70
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million people in the United States alone, and 112 million people globally. Despite this, 4 in 10 patients undergoing elective coronary angiography for angina and ischemia do not have evidence of obstructive coronary artery disease (CAD). This condition of ischemia with no obstructive CAD (INOCA) is associated with high clinical and economic morbidity, as these patients have a higher rate of repeat procedures and hospitalizations, worse quality of life, future adverse cardiovascular events and frequent time missed from work. The overall objective of this study is to develop and validate a non-invasive algorithm for diagnosis and management of patients with INOCA and suspected microvascular dysfunction centered around cardiac PET MPI. A secondary goal of the study is to assess for improvement in patient symptoms, function and quality of life from PET-guided management of CMD in patients with INOCA. This study will take place at Mount Sinai Morningside in the PET and CTunit on the 3rd floor. The sub-study will occur at Mount Sinai Morningside Cath Lab on the 3rd floor. The study will enroll an estimated total of 70 subjects, 12 of which will also participate in the sub-study. The study is estimated to last 2 years.
CONDITIONS
Official Title
Imaging Coronary Microvascular Dysfunction (CMD) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptoms of exertional angina and/or dyspnea confirmed by questionnaires
- Evidence of non-obstructive coronary artery disease with no artery narrowing greater than 50% and/or normal FFR if performed
You will not qualify if you...
- Reduced left ventricular ejection fraction below 50% or diagnosis of cardiomyopathy
- Moderate or severe valve disease
- Kidney function with eGFR less than 30 ml/min/m2
- History of prior coronary revascularization
- Non-coronary reasons for coronary CT angiogram or coronary angiogram
- Contraindications to regadenoson such as severe asthma, COPD, slow heart rhythms, or low blood pressure
- Inability to provide informed consent
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Morningside
New York, New York, United States, 10025
Actively Recruiting
Research Team
L
Lilia Soriano, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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