NCT02092428

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

Contrast- Enhanced Whole-Heart Coronary Magnetic Resonance Angiography (MRA) at 3.0T

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Image Quality	The following procedures may be conducted as part of this study: * Coronary MRI scan with no contrast * Coronary MRI scan enhanced with a gadolinium-based contrast agent (Optimark, MultiHance, Ablavar) administered intravenously at a total dose of up to 0.2 mmol/kg * MRI scan with an oral beta blocker (metoprolol) * Cardiac Stress Test MRI scan with a pharmacologic stress drug; either adenosine (dosage depends on the subject's weight and is set at 140mcg/kg/min) or regadenoson (0.4mg/5ml bolus) Determination of study drugs will be made depending upon study focus, subjects' health conditions, blood pressure, heart rate and concomitant medications. Both groups are eligible for all combinations of interventions.
OTHER	Diagnostic Accuracy	Both groups are eligible for all combinations of interventions. This arm will also include collection of conventional x-ray angiography.

Timeline

• Start date: 2011-04-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2014-03-20
• Last updated: 2018-03-23

Locations

1 site across 1 country: United States