NCT04224714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

January 8, 2020

Last Update Submit

January 9, 2020

Conditions

Myocardial Ischemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • IMR

    Resistance index of microcirculation

    one hour

Study Arms (1)

Coronary heart disease patient

EXPERIMENTAL

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

FFRCOMBINATION_PRODUCT

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.

Coronary heart disease patient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The people's hospital of LiaoNing Province

Shenyang, Liaoning, 110016, China

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

September 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

CN(1)