Imaging Coronary Microvascular Dysfunction (CMD) Study

ID#: NCT05634031

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Enrolling by invitation

Start Date: April 26, 2023

End Date: December 01, 2024

Summary: 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.
Eligibility:

Inclusion criteria:

- Patients with symptoms of exertional angina and/or dyspnea (confirmed on Seattle Angina Questionnaire and Rose Dyspnea Questionnaire)

- Evidence of non-obstructive CAD on CCTA or coronary angiography (no stenosis >50% and/or FFR if performed >0.80)

Exclusion criteria:

- Patients with reduced LVEF (<50%) or diagnosis of cardiomyopathy

- Patients with co-existent moderate or severe valve disease

- Patients with eGFR <30 ml/min/m2

- History of prior coronary revascularization

- Non-coronary indication for CCTA or coronary angiogram determining eligibility

- Contraindications to regadenoson (severe asthma/chronic obstructive pulmonary disease, brady-arrhythmias, or systolic blood pressure <90 mm Hg)

- Inability to provide informed consent

- Pregnancy
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