About this trial
The coronary angiography-derived index of microcirculatory resistance (caIMR) can be used to provide a binary assessment whether patients(with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, and without cardiomyopathy or obstructive epicardial coronary artery disease) have microcirculatory dysfunction, using a cutoff value of 25.
This study aims to evaluate the binary classification performance of caIMR in two specific groups of patients: (1) those with caIMR values between 20 and 30, and (2) those with diffuse disease. We will do this by looking at differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes over a three-year period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years, regardless of gender;
Diagnosed with stable angina, unstable angina, or suspected myocardial ischemia;
targeted vessel stenosis < 50% and caIMR values between 20 and 30; or
Disqualifiers
Previously undergone percutaneous coronary intervention (PCI);
History of heart failure or myocardial infarction;
Acute myocardial infarction;
Primary or secondary cardiomyopathy;
Trial population
This study will enroll patients with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, who do not have cardiomyopathy or obstructive epicardial coronary artery disease. Specifically, we will focus on two groups: (1) patients with caIMR values between 20 and 30, and (2) patients with diffuse disease.
Trial design
Other
Prospective
Treatments tested in this trial
caIMR
DevicecaIMR will be measured by pressure sensors which are produced by Suzhou Rainmed Medical Technology Co., Ltd. caIMR is calculated based on angiography images and Hyperemic Pa estimated from resting Pa according to prespecified equation
Treatment groups
Trial outcomes
Primary outcomes
Patients' Seattle Angina Questionnaire (SAQ) scores
The Seattle Angina Questionnaire (SAQ) is a rigorously validated disease-specific health status assessment tool widely used to evaluate symptoms, functional status, and quality of life in patients with coronary artery disease (CAD). Utilizing the SAQ as an endpoint in clinical trials ensures the scientific validity and comparability of study results, providing valuable insights for clinical practice.
Secondary outcomes
MACE (Major Adverse Cardiovascular Events)
It is defined as a composite endpoint including cardiovascular death, target vessel revascularization, myocardial infarction, rehospitalization for angina, heart failure, and stroke.
Locations
Sponsors and contacts
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