A Multi-center, Real-World Clinical Trial of caIMR on Two Specific Kinds of Patients.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGe Junbo

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • caIMR

    Device

    caIMR 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

508 Participants
are divided into 2 treatment groups
Group A: Grey zone patients1 intervention
Group B: Diffuse disease patients.1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before the procedure and six months post-procedure.

Secondary outcomes

1

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.

Time frame
At 6 months, 1 year, 2 years, and 3 years post-procedure.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ge Junbo

Lead sponsor

Fudan University

Sponsor institution

RainMed Medical Group

Collaborator

This trial is not recruiting at the moment. You can still explore other options: