Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients (RECAD-AF)
|ClinicalTrials.gov Identifier: NCT01710254|
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : November 7, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Coronary Artery Disease||Drug: Regadenoson MRI Drug: Gadobenate dimeglumine||Phase 2|
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Atrial fibrillation (AF) is a large and growing healthcare problem worldwide. Over 7 million people in the U.S. and Europe currently suffer from atrial fibrillation, and this number is expected to double before 2050. The lifetime risk of AF is high: ~24% at age 40, and this risk remains fairly constant at older ages, with 22% lifetime risk at age 80 . AF significantly increases the risk of stroke and mortality, and can greatly limit quality of life. Little research has been done on AF and ischemic cardiomyopathy, though it is a relatively common co-morbidity. CT found increased prevalence (41% vs 27%) of coronary artery disease (CAD) in patients with AF compared to patients with similar pre-test risk but no AF . AF patients with a positive SPECT scan for CAD have a worse prognosis for cardiac events than patients with positive SPECT but without AF . It was recently reported that in a study of 253 AF patients, that AF patients with positive SPECT studies had a very high number of false positives - only 15% of patients had significant CAD by angiography (compared to 67% in the control group) [4, 5]. Just over half of the patients were in sinus rhythm at SPECT, but since similar numbers of positives were seen in each half, the authors did not feel that imaging during AF was the cause of the poor specificity.
Use of MRI for assessment of CAD is a growing area that entails no radiation exposure to the patient. Advances in MRI have made it possible to accurately detect CAD, either as well or better than SPECT in unselected populations [6, 7]. However, adoption of MRI myocardial perfusion scans has been limited in part due to the challenges associated with the use of adenosine. Adenosine requires starting a second IV, and to use either a special expensive MRI-compatible infusion pump to deliver the drug, or long lengths of tubing to run to a pump outside the scanner room. Neither solution is ideal, and regadenoson would not require any such pumps or the starting of a second IV. Here the investigators propose to determine the sensitivity/specificity for dynamic contrast-enhanced myocardial perfusion MRI with the vasodilator regadenoson in a subpopulation of patients - those with atrial fibrillation.
The investigators have a great deal of experience with stress and rest myocardial perfusion MRI. In a preliminary study imaging three patients with AF that then went to X-ray angiography (cath), two of the three subjects had significant stenoses by cath, and one did not. This agreed with the regadenoson stress perfusion MRI findings. These MRI acquisitions were performed on a Siemens Verio MRI scanner. The Verio operates at twice the magnetic field strength (3 Tesla, or 3T) of most MRI scanners, which operate at 1.5T. The higher magnetic field offers images with significantly less noise (almost twice the signal-to-noise ratio).
Objective: To demonstrate sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and adenosine (90%/80% [6, 7]), in an atrial fibrillation population while using the time-efficient vasodilator regadenoson that requires only a single IV.
Study Design: This will be a prospective, open-label, comparative trial using MRI. Non-invasive MRI measurements of resting flow and flow at regadenoson stress will be obtained in each subject during a one hour MRI exam using our advanced MRI acquisition techniques. Sensitivity/specificity of regadenoson stress MRI will be determined using x-ray angiography as the standard. X-ray angiography will be done as standard-of-care, and is not an intervention of this clinical trial.
Study Procedure: Each subject will undergo a single MRI scanning session. Caffeine will be stopped 12 hours prior to the procedure. One IV will be started and subjects positioned in the scanner. Resting perfusion with Multihance Gd-BOPTA contrast agent will be performed first. The perfusion acquisition acquires 3-6 short axis slices each heartbeat and lasts for one minute. Then a standard regadenoson injection of 400ug/5cc will be given and MR imaging performed with a Gd-BOPTA contrast agent bolus 60-100 seconds later  .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Coronary Artery Disease in Patients With Atrial Fibrillation Using Regadenoson Stress MRI|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
U.S. FDA Resources
Experimental: Regadenoson MRI
Participants with AF receiving regadenoson stress MRI, using Gadobenate dimeglumine
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: LexiscanDrug: Gadobenate dimeglumine
Resting perfusion with Multihance Gd-BOPTA contrast agent will be performed first, then a regadenoson injection will be given and MR imaging performed with a Gd-BOPTA contrast agent bolus 60-100 seconds later.
- Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) [ Time Frame: one MRI, up to 1 hour ]Determination of sensitivity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.
- Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) [ Time Frame: one MRI, up to 1 hour ]Determination of specificity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.
- Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) [ Time Frame: one MRI, up to 1 hour ]Determination of accuracy of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Accuracy is the percentage of correctly classified subjects (true positive + true negative) among all subjects (true positive + true negative + false positive + false negative). Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710254
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Brent Wilson, MD||University of Utah|