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

April 24, 2025 updated by: Ge Junbo

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The coronary angiography-derived index of microcirculatory resistance (caIMR) is a novel, non-invasive, imaging-based functional index for diagnosing coronary microvascular disease, which has been clinically validated for market release. It can be used to provide a binary assessment of whether patients with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50% (without cardiomyopathy or obstructive epicardial coronary artery disease) have microcirculatory dysfunction, using a cutoff value of 25.

This trial is a prospective, multicenter, observational real-world study. We will regularly collect clinical diagnostic data (including angiographic images) patients who undergo caIMR measurement using the Coronary Artery Functional Measurement System and single-use pressure sensors as part of their routine medical care. After verifying the inclusion and exclusion criteria, patients who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled in this trial.

The primary objective of this trial is to evaluate the binary classification performance of caIMR by comparing patients' Seattle Angina Questionnaire (SAQ) scores before the procedure and at six months post-procedure in two specific groups of patients: :

  1. Assessing the binary classification performance of caIMR in patients with values between 20 and 30.
  2. Assessing the binary classification performance of caIMR in patients with diffuse disease.

The secondary objective is to validate the prognostic value of caIMR in these two groups of patients based on the occurrence of major adverse cardiovascular events (MACE) over a three-year period.

Study Type

Observational

Enrollment (Estimated)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  1. Age between 18 and 80 years, regardless of gender;
  2. Diagnosed with stable angina, unstable angina, or suspected myocardial ischemia;
  3. targeted vessel stenosis < 50% and caIMR values between 20 and 30; or

(3) Targeted vessel stenosis < 50%, but with lesion length > 20 mm and caFFR > 0.8, representing diffuse disease.

Exclusion Criteria:

  1. Previously undergone percutaneous coronary intervention (PCI);
  2. History of heart failure or myocardial infarction;
  3. Acute myocardial infarction;
  4. Primary or secondary cardiomyopathy;
  5. Primary or secondary severe valvular heart disease;
  6. Severe systemic infections;
  7. Malignant cachectic diseases and an estimated survival of less than one year;
  8. Patients who are currently participating in other clinical trials involving drugs or devices and have not yet reached the primary endpoint of those trials;
  9. Patients whom the investigator deems to have other conditions that make them unsuitable for participation in the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Grey zone patients
Patients with caIMR values between 20 and 30 can be enrolled in this group, a total of 254 patients of this type will be enrolled in the study.The binary classification performance of caIMR will be validated based on differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes.
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
Diffuse disease patients.
Patients with diffuse coronary disease and less than 50% stenosis can be enrolled in this group, a total of 254 patients of this type will be enrolled in the study. CaIMR will be assessed in these patients, and its binary classification performance will be validated based on differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Seattle Angina Questionnaire (SAQ) scores
Time Frame: Before the procedure and six months post-procedure.
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.
Before the procedure and six months post-procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (Major Adverse Cardiovascular Events)
Time Frame: At 6 months, 1 year, 2 years, and 3 years post-procedure.
It is defined as a composite endpoint including cardiovascular death, target vessel revascularization, myocardial infarction, rehospitalization for angina, heart failure, and stroke.
At 6 months, 1 year, 2 years, and 3 years post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ge Junbo

Collaborators

RainMed Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FlashV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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