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

Primary Purpose

Myocardial Ischemia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

FFR

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring microcirculation resistance index (IMR), fractional flow reserve(FFR)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The people's hospital of LiaoNing Province

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronary heart disease patient

Arm Description

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

Outcomes

Primary Outcome Measures

IMR

Resistance index of microcirculation

Secondary Outcome Measures

Full Information

NCT ID

NCT04224714

First Posted

January 8, 2020

Last Updated

January 9, 2020

Sponsor

The People's Hospital of Liaoning Province

1. Study Identification

Unique Protocol Identification Number

NCT04224714

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The People's Hospital of Liaoning Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Ischemia

Keywords

microcirculation resistance index (IMR), fractional flow reserve(FFR)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coronary heart disease patient

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

FFR

Intervention Description

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.

Primary Outcome Measure Information:

Title

IMR

Description

Resistance index of microcirculation

Time Frame

one hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Facility Information:

Facility Name

The people's hospital of LiaoNing Province

City

ShenYang

State/Province

Liaoning

ZIP/Postal Code

110016

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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