Imaging Coronary Microvascular Dysfunction (CMD) Study
- Conditions
- Non-obstructive Coronary Artery DiseaseAngina
- Interventions
- Radiation: PET imagingRadiation: Coronary CT angiogramProcedure: Functional AngiographyProcedure: Treadmill exercise stress study
- Registration Number
- NCT05634031
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief 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.
- Detailed 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 invited to participate in the invasive angiographic validation cohort and will undergo an invasive functional angiography with measurement of FFR, CFR, IMR and Ach-vasoreactivity testing to obtain validation data for PET-guided diagnosis of CMD. A short questionnaire of symptom, suspected diagnosis and planned management will be administered to the treating physician prior to and post-study enrollment.
Patient risk factors, symptoms, health status, medications will be collected using standardized data collection form on study enrollment.
For Aim 2, the cardiac PET findings will be made available to the treating clinician.
A positive PET result for endothelial-independent CMD will be defined as global MBFR \<2. A positive PET result for endothelial-dependent CMD will be defined as MBF with cold-pressor test \<=40%.
If there was evidence of CMD on cardiac PET, specific treatment recommendations will be made available to the treating physician. These recommendations will include consideration of aspirin, statin and ACE-inhibitors in all patients, beta-blockers (eg: carvedilol 6.25 mg BID with uptitration) as first line, non-dihydropyridine calcium channel blockers (cardizem and verapamil) as second line, and amlodipine (in combination with beta-blocker) or ranolazine as third-line therapy.
Patient symptoms and health status and downstream resource utilization (ER admissions for chest pain, use of other invasive or non-invasive diagnostic procedures for CAD) will be collected at 3 months.
Invasive physiology measurements will be made available to the treating clinician along with recommended management based on INOCA endotype (corMICA trial treatment algorithm) at completion of 3 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with INOCA PET imaging Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease. Patients with INOCA Treadmill exercise stress study Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease. Patients with INOCA Coronary CT angiogram Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease. Patients with INOCA Functional Angiography Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease.
- Primary Outcome Measures
Name Time Method The Seattle Angina Questionnaire (SAQ) 3 months The Seattle Angina Questionnaire (SAQ) is a 7-item self-administered questionnaire with a 4-week recall period measuring health status in patients with CAD across 3 domains: physical limitation (PL), angina frequency (AF), and quality of life (QoL). Full scale from 0-100, with higher score indicating better health outcome.
Rose Dyspnea Scale (RDS) 3 months Rose Dyspnea Scale (RDS) is a 4-item questionnaire with a 1-month recall period that assesses patients' level of dyspnea with common activities. Full scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea. Higher score indicates poorer health outcomes.
Number of ER admissions for chest pain per participant 3 months The number of ER admissions for chest pain per participant.
Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS) 3 months Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS) The EQ-5D gives a measure of health-related quality of life. The visual analogue score is a measure of overall self-rated health status with full scale from 0-100. Higher scores indicate better health outcomes.
Number of use of other invasive or non-invasive diagnostic procedures for CAD 3 months The number of use of other invasive or non-invasive diagnostic procedures for CAD
- Secondary Outcome Measures
Name Time Method The Bruce protocol score within 3 months of patient enrollment Sub group: Treadmill Exercise Stress Test to obtain mean values of exercise capacity (metabolic equivalents, METs) will be assessed for patients with and without CMD as defined on PET.
The Bruce protocol for exercise test uses a series of calculations to determine a subject's score. This score then indicates physical fitness and the presence of coronary heart disease. The Bruce protocol uses the following calculations: VO2max (ml/kg/min) = 14.76 - (1.379 × T) + (0.451 × T²) - (0.012 × T³) Women: VO2max (ml/kg/min) = 2.94 x T + 3.74 Young Women: VO2max (ml/kg/min) = 4.38 × T - 3.9 Men: VO2max (ml/kg/min) = 2.94 x T + 7.65 Young Men: VO2max (ml/kg/min) = 3.62 x T + 3.91.Number of participants with METs >=10 METS within 3 months of patient enrollment Prevalence of CMD will be assessed among patients with preserved (METs \>=10 METS) and reduced exercise capacity.
Trial Locations
- Locations (1)
Mount Sinai Morningside
🇺🇸New York, New York, United States