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NOT YET RECRUITING
NCT06945094

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

Sponsor: Ge Junbo

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-center, Real-World Clinical Trial on Assessment of Microcirculatory Status Using Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR) (Flash V)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

508

Start Date

2025-07-01

Completion Date

2029-12-30

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

DEVICE

caIMR

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