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

NCT06945094 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 508

Last updated 2025-04-27

No results posted yet for this study

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.

Conditions

  • Coronary Microvascular Dysfunction (CMD)
  • Stable Angina Pectoris
  • Unstable Angina Pectoris
  • Myocardial Ischemia, Angina Pectoris

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

Sponsors & Collaborators

  • RainMed Medical Group

    collaborator INDUSTRY

  • Ge Junbo

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-12-30
Completion
2029-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945094 on ClinicalTrials.gov