Viewing Study NCT02092428



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Last Modification Date: 2024-10-26 @ 11:21 AM
Study NCT ID: NCT02092428
Status: COMPLETED
Last Update Posted: 2018-03-23
First Post: 2014-03-04

Brief Title: Contrast- Enhanced Whole-Heart Coronary MRA at 30T Tesla
Sponsor: Cedars-Sinai Medical Center
Organization: Cedars-Sinai Medical Center

Study Overview

Official Title: Contrast- Enhanced Whole-Heart Coronary Magnetic Resonance Angiography MRA at 30T
Status: COMPLETED
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 comparisonThis is a one-day research procedure Studies are acquired from the approved Institutional Review Board 25881 Cedars-Sinai Biomedical Imaging Research Registry

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5R01EB002623-07 NIH None httpsreporternihgovquickSearch5R01EB002623-07