Clinical Study on the Correlation Between IMR（Index of Microcirculation Resistance） and FFR（Fractional Flow Reserve）

January 9, 2020 updated by: Zhilin Miao, The People's Hospital of Liaoning Province
To study the effect of myocardial microcirculation disturbance on coronary flow reserve fraction, compare the evaluation value of IMR, FFR and QCA on myocardial ischemia, and discuss the correlation among them.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, 60 patients with critical lesions indicated by coronary angiography will be admitted. The investigators collected the basic clinical data (gender, age, body mass index, smoking history, hypertension, diabetes, hyperlipidemia), laboratory data (creatinine, cholesterol, triglycerides) and measured their FFR and IMR.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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
    • Liaoning
      • ShenYang, Liaoning, China, 110016
        • The People's Hospital of Liaoning Province

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:(1) Age: 18-75 years old, unlimited for men and women;

(2) Quantitative coronary angiography (QCA) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm;

(3) Agree to participate in the study and sign informed consent

-

Exclusion Criteria:(1) Patients with acute myocardial infarction within one month;

(2) Patients with congenital heart disease, severe valve disease, dilated cardiomyopathy, pulmonary heart disease and hypertrophic cardiomyopathy;

(3) With severe heart failure (NYHA cardiac function grade ≥ grade III or left ventricular ejection fraction < 35%);

(4) Patients with less than 1 year of stent implantation or with coronary artery bypass grafting;

(5) Patients with left main lesion, severe distorted calcification, open lesion, bifurcated lesion or complete occlusion;

(6) Patients with severe hepatorenal insufficiency;

(7) Contraindications to adenosine, aspirin and clopidogrel;

(8) Patients with advanced tumor or life expectancy less than 1 year;

(9) Patients with severe asthma or uncontrolled asthma;

(10) Women in pregnancy.

-

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coronary heart disease patient
Quantitative coronary angiography (QCA) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm
Combination product: FFR
FFR measurement: Pressure guid wire(radianalyzer Xpress 12711) is produced in Switzerland. After the pressure of the aorta and the pressure guide wire is balanced, Send the pressure guide wire to the distal part of the lesion(more than 20 mm away from the lesion) . Adenosine is injected into the vein,then,record the FFR index 3 times and take the average value as the final measurement index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IMR
Time Frame: one hour
Resistance index of microcirculation
one hour

Collaborators and Investigators

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

Sponsor

The People's Hospital of Liaoning Province

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)

September 1, 2019

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-91616

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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