Correlation Between Quantitative Analysis of Coronary MRA and FFR

• Conditions: Fractional Flow Reserve; Coronary Artery Disease; Magnetic Resonance Angiography

• Registration Number: NCT03117218
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.

Detailed Description

Coronary MR angiography is performed with a 3.0-T imager with 32-channel coils. Qunatitative analysis of coronary MR angiogram is evaluated on the basis of the signal intensity (SI) profile along the vessel. Quantitative analysis of coronary MR angiogram (QCMRA) is calculated as \[1 - (SImin/SIref)\] x 100, where SImin is minimal SI and SIref is corresponding reference SI. Diagnostic performance of quantitative analysis of coronary MR angiogram for predicting functional significant coronary stenosis was evaluated by using fractional flow reserve (FFR) as the reference standard.

Study Timeline

• Study Start: 2014-07-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-16
• Study First Posted: 2017-04-17
• Last Update Posted: 2017-04-18
• Primary Completion: 2017-12-31
• Study Completion: 2018-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Age ≥ 18 years
• 1 or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary MR angiogram
• Patient who were planned to undergo invasive coronary angiography and fractional flow reserve

Exclusion Criteria

• clinically unstable patient
• a history of coronary revascularization
• infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis
• contraindication to use of adenosine
• complete occlusion of target lesion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of functionally significant coronary stenosis	within 1 month	fractional flow reserve \< 0.8

Trial Locations

Locations (1)

Seoul National University Bundang Hopsital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of