A Phase 1 interventional study of Image Quality and Diagnostic Accuracy in Coronary Artery Disease, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by Cedars-Sinai Medical Center · Phase 1, Interventional, and Diagnostic
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:
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 333 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion:
Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to compare image quality between contrast and non-contrast scans.
Other: Image Quality
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
Other: Diagnostic Accuracy
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.
Also known as: MRI with contrast, contrast-enhance MRI, non-contrast MRI, gadolinium-based contrast, adenosine, regadenoson
Both groups are eligible for all combinations of interventions. This arm will also include collection of conventional x-ray angiography.
Also known as: conventional x-ray angiography., contrast-enhanced MRI, non-contrast MRI, gadolinium-based contrast, adenosine, regadenoson
Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)
sensitivity and specificity
Time frame: one day
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center