A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR) (Flash III)

March 28, 2022 updated by: Ge Junbo

A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Coronary Angiography-Derived Index of Microcirculatory Resistance Measured Online by a Coronary Functional Measurement System

More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation. The aim of the trial is to assess diagnostic performance of caIMR, using wire-derived index of microcirculatory resistance (IMR) as the reference standard.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. Presently, the index of microcirculatory resistance (IMR) measured by the pressure wire is recognized as standard for evaluating coronary microcirculatory function. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation without pressure wire, hyperemic agents, or thermodilution method.

This study is a prospective, multi-center clinical trial. In the study, IMR (measured by pressure wire) will be used as a reference standard to evaluate the feasibility, accuracy and safety of caIMR measured by a non-invasive diagnosis system (FM21a) based on angiography images and aortic pressure wave. 116 patients eligible for inclusion criteria will be enrolled in the study. Both IMR and caIMR measurement will be performed in the same patient in a random order after angiography. The definitions of IMR and caIMR for coronary microcirculatory ischemia are IMR≥25 and caIMR≥25. The primary endpoint is the diagnostic accuracy of caIMR. The secondary endpoint is caIMR's sensitivity, specificity, positive predictive value, negative predictive value, ROC curve and AUC of caIMR diagnosis, and the diagnostic characteristics of caIMR at the vascular level.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University first hospital
    • Hubei
      • Wuhan, Hubei, China, 430062
        • Zhongnan Hospital Of Wuhan Uniersity
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stable or unstable angina, or suspected myocardial ischemia.

Description

Inclusion Criteria:

  1. Patients aged 18 years and above, 80 years old and below, with no gender limitation;
  2. Patients with stable or unstable angina or suspected myocardial ischemia;
  3. Patients voluntarily participated in this clinical trial and signed an informed consent form;
  4. Target coronary with <50% diameter stenosis (DS%) by visual estimation.

Exclusion Criteria:

  1. Patients with suspected acute myocardial infarction;
  2. Patients with old myocardial infarction;
  3. Patients with primary or secondary cardiomyopathy;
  4. Patients with primary or secondary heart valve disease;
  5. Patients with severe cardiac insufficiency and LVEF≤35%;
  6. Patients with renal insufficiency (eGFR<60ml/min (1.73m^2)) or patients undergoing dialysis;
  7. Patients who are allergic to iodine contrast agents, adenosine, and ATP;
  8. Patients with severe organ disease or life expectancy less than 24 months;
  9. Patients who are participating in other clinical studies of investigational drugs or devices and have not reached their primary endpoint;
  10. The patient who has other conditions that are not suitable for clinical trials;
  11. Patients with coronary artery involved in coronary fistula and myocardial bridge;
  12. The contrast media is not filled, the blood vessels are overlapped, or the target blood vessel is severely distorted, and the lesion location cannot be fully exposed, or the image quality is poor and cannot be recognized;
  13. Left main coronary artery disease and right coronary artery orifice disease;
  14. After angiography, the investigator believes that the patient cannot tolerate any of the detection methods between caIMR and IMR;
  15. The investigator believes that the patient is not suitable for clinical trials after angiography;

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
IMR first group
In this group, IMR based on pressure wire and arterial physiological detector will be measured first, and then caIMR base on angiography images and pressure sensor will be measured secondly.
Device: Angiography-derived Index of Microcirculatory Resistance

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.

Device: Pressure wire-based Index of Microcirculatory Resistance

IMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical.

IMR = Pd ∙Tmn
caIMR first group
In this group, caIMR based on angiography images and pressure sensor will be measured first, and then IMR based on pressure wire and arterial physiological detector will be measured secondly.
Device: Angiography-derived Index of Microcirculatory Resistance

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.

Device: Pressure wire-based Index of Microcirculatory Resistance

IMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical.

IMR = Pd ∙Tmn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: Through study completion, an average of 7 months.
To compare diagnostic accuracy of caIMR for coronary microvascular dysfunction with IMR as control.
Through study completion, an average of 7 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive predictive value, and negative predictive value
Time Frame: Through study completion, an average of 7 months.
To compare the diagnostic performance between caIMR and IMR in the patient level, with IMR as the reference standard.
Through study completion, an average of 7 months.
ROC curve, and AUC
Time Frame: Through study completion, an average of 7 months.
Using IMR as reference standard, draw the ROC curve of caIMR. The definition of ischemia is IMR≥25.
Through study completion, an average of 7 months.
Diagnostic performance on the vessel level
Time Frame: Through study completion, an average of 7 months.
The diagnostic features of caIMR compared with IMR on the vessel level.
Through study completion, an average of 7 months.

Collaborators and Investigators

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

Sponsor

Ge Junbo

Collaborators

RainMed Medical

Investigators

  • Study Director: Junbo Ge, PHD, Fudan University

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 (Actual)

October 14, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Flash III

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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