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NCT03117218 Clinical Trial

Correlation Between Quantitative Analysis of Coronary MRA and FFR

Coronary Artery Disease Clinical Trial

Official title:
Quantitative Analysis of 3T Whole Heart Coronary Magnetic Resonance Angiogram Improves Detection of Functionally Significant Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03117218
Other study ID # B-1408/262-006
Secondary ID
Status Recruiting
Phase N/A
First received April 12, 2017
Last updated April 16, 2017
Start date July 1, 2014
Est. completion date May 31, 2018

Study information
Verified date April 2017
Source Seoul National University Bundang Hospital
Contact Yeonyee E Yoon, MD
Phone +82-31-787-7072
Email yeonyeeyoon@snubh.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 89
Est. completion date May 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Coronary MR angiography
Quantitative analysis of coronary MR angiogram

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hopsital Seongnam Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of functionally significant coronary stenosis fractional flow reserve < 0.8 within 1 month
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