Development and Validation of a Non-invasive Algorithm for Diagnosis of Microvascular Angina Among Patients With Ischemia and Non-obstructive Coronary Artery Disease (IMAGING-CMD Study)
Icahn School of Medicine at Mount Sinai
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.
Description
All patients will be consented and will undergo Rb-82 rest-stress myocardial perfusion imaging PET with flow quantitation using vasodilator (regadenoson preferred) stressor and cold pressor test and an exercise treadmill test according to standard modified Bruce protocol (if able to exercise). Only the patients who do not have a recent coronary CT angiography will be consented for undergoing a coronary CT angiography for measurement of plaque burden and quantification of extent and degree of epicardial stenosis. A small subset of patients who have abnormal flow parameters on PET will be invi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Contraindi…
Interventions
- RadiationPET imaging
PET imaging visit, which will take approximately 1-2 hours.
- RadiationCoronary CT angiogram
A coronary CT angiogram if the participant has not had one recently.
- ProcedureFunctional Angiography
A subset of patients with abnormal results on cardiac PET myocardial perfusion imaging study (estimated number of patients = 12) will be invited to participate in an invasive sub-study wherein they would undergo detailed invasive coronary physiology evaluation. Functional Angiography (coronary reactivity test- CRT): is an angiography procedure done in the catheterization laboratory. It evaluates the coronary artery microcirculation and how the blood vessels respond to different medications.
- ProcedureTreadmill exercise stress study
A treadmill exercise stress study
Location
- Mount Sinai MorningsideNew York, New York