Contrast- Enhanced Whole-Heart Coronary MRA at 3.0T (Tesla)

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Image Quality; Other: Diagnostic Accuracy

• Registration Number: NCT02092428
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

Investigators at the Biomedical Imaging Research Institute (BIRI) at Cedars-Sinai Medical Center have developed a Magnetic Resonance Imaging (MRI) method for imaging coronary arteries using slow-infusion, contrast-enhanced data acquisition. This method allows faster data acquisition and better spatial resolution.

Specific aims of this study are to:

1. compare coronary artery imaging with and without contrast media on both healthy subjects and patients;

2. assess the accuracy of coronary MRI in detecting coronary artery disease as compared to conventional x-ray angiography

Researchers hypothesize that contrast-enhanced MRI will improve the delineation of coronary arteries over non-contrast-enhanced MRI and that optimized, contrast-enhanced coronary MRI technique will accurately detect coronary artery disease (CAD) as compared to conventional x-ray angiography.

Detailed Description

This is a study to compare image quality between contrast and non-contrast cardiac MR and to evaluate the diagnostic accuracy of a cardiac MRI procedure in a patient population that includes both healthy volunteers and a study group of patients with known CAD who are scheduled for clinical coronary angiography within one month of signing informed consent. Both groups are eligible for a combination of imaging tests. Subjects may receive either a non-contrast MRI or a contrast-enhanced MRI depending upon their kidney function and study focus. Also based upon the focus of the study at the time of the scan and to improve image quality, a beta-blocker to lessen motion artifact in patients with higher heart rates may be administered or patients may be asked to undergo a stress test for comparison.This is a one-day research procedure. Studies are acquired from the approved Institutional Review Board #25881 Cedars-Sinai Biomedical Imaging Research Registry.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Image Quality	Image Quality	Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to compare image quality between contrast and non-contrast scans.
Diagnostic Accuracy	Diagnostic Accuracy	Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to assess the diagnostic accuracy of coronary MRI in detecting CAD as compared to conventional x-ray angiography

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)	one day	sensitivity and specificity

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States