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

Not Applicable

• Conditions: Myocardial Ischemia
• Interventions: Combination Product: FFR

• Registration Number: NCT04224714
• Lead Sponsor: The People's Hospital of Liaoning Province

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.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-09
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary heart disease patient	FFR	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

Primary Outcome Measures

Name	Time	Method
IMR	one hour	Resistance index of microcirculation

Trial Locations

Locations (1)

The people's hospital of LiaoNing Province; 🇨🇳 ShenYang, Liaoning, China