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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Combination Product: FFR


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary heart disease patient<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microcirculation resistance index (IMR), fractional flow reserve(FFR)