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Status unknownNCT04224714Updated Jan 13, 2020

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

An interventional study of FFR in Myocardial Ischemia, sponsored by The People's Hospital of Liaoning Province. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by The People's Hospital of Liaoning Province · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myocardial Ischemia

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Keywords

  • microcirculation resistance index (IMR)
  • fractional flow reserve(FFR)
03

In context

Myocardial Ischemia

3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

The People's Hospital of Liaoning Province is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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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.

-

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • Combination productFFR

    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.

06

What researchers measure

Primary outcomes

  1. IMR

    Resistance index of microcirculation

    Time frame: one hour

07

Study locations

1 site
  • The people's hospital of LiaoNing Province
    ShenYang, Liaoning 110016, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04224714
Lead sponsor
The People's Hospital of Liaoning Province
Responsible party
Zhilin Miao (Chief physician, The People's Hospital of Liaoning Province) — Principal investigator
First posted
Jan 13, 2020
Start date
Sep 1, 2019
Primary completion
Sep 30, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Jan 13, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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