Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients (RECAD-AF)
Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed with AF. The objective of this study is to demonstrate the utility of MRI in assessment of coronary artery disease. The specific objective is to demonstrate sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in an AF population using the time-efficient vasodilator regadenoson that requires only a single intravenous (IV).
Coronary Artery Disease
Drug: Regadenoson MRI
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Detection of Coronary Artery Disease in Patients With Atrial Fibrillation Using Regadenoson Stress MRI|
- Sensitivity/specificity [ Time Frame: one MRI ] [ Designated as safety issue: No ]
All of the resting and stress scans of the subjects will be interpreted as positive or negative for CAD by two blinded expert readers.
Sensitivity/specificity will be calculated overall and subdivided into single vessel disease, two vessel, and three vessel disease. Confidence limits will also be calculated.
- Sensitivity/specificity image quality [ Time Frame: one MRI ] [ Designated as safety issue: No ]comparison of MRI image quality between subjects who were in normal sinus rhythm versus subjects who had an arrhythmia during the MRI
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Regadenoson MRI
Participants with AF receiving regadenoson stress MRI
Drug: Regadenoson MRI
AF patients will be provided with a regadenoson stress MRI to see if coronary artery disease can be detected with more sensitivity /specificity.
Other Name: Lexiscan
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01710254
|Contact: Christopher J McGann, MDfirstname.lastname@example.org|
|Contact: Lisa Dubler, CCRC||8015878190||Lisa.Dubler@hsc.utah.edu|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator: Christopher J McGann, MD|
|Sub-Investigator: Edward VR DiBella, PhD|
|Sub-Investigator: Brent D Wilson, MD/PhD|
|Principal Investigator:||Christopher J McGann, MD||University of Utah|