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Clinical Trials/NCT04224714
NCT04224714
Unknown
Not Applicable

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

The People's Hospital of Liaoning Province1 site in 1 country60 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Ischemia
Sponsor
The People's Hospital of Liaoning Province
Enrollment
60
Locations
1
Primary Endpoint
IMR
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
September 30, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
The People's Hospital of Liaoning Province
Responsible Party
Principal Investigator
Principal Investigator

Zhilin Miao

Chief physician

The People's Hospital of Liaoning Province

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.

Outcomes

Primary Outcomes

IMR

Time Frame: one hour

Resistance index of microcirculation

Study Sites (1)

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