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Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients (RECAD-AF)

This study has been completed.
Information provided by (Responsible Party):
Brent Wilson, University of Utah Identifier:
First received: October 2, 2012
Last updated: November 1, 2016
Last verified: November 2016
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).

Condition Intervention Phase
Atrial Fibrillation
Coronary Artery Disease
Drug: Regadenoson MRI
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Sensitivity/specificity [ Time Frame: one MRI ]

    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.

Secondary Outcome Measures:
  • Sensitivity/specificity image quality [ Time Frame: one MRI ]
    comparison of MRI image quality between subjects who were in normal sinus rhythm versus subjects who had an arrhythmia during the MRI

Enrollment: 32
Study Start Date: January 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease who will undergo catheterization X-ray angiography

Exclusion Criteria:

  1. Critically ill patients, patients on ventilators patients with hypotension, asthmatics, and other patients whose medical care or safety may be compromised from undergoing an MRI examination will be excluded.
  2. Patients with claustrophobia will also be excluded since MRI is conducted in a closed environment.
  3. Patients with contraindications to MRI (pacemaker, metal implants).
  4. Pregnant subjects (or women who may become pregnant), minors, and prisoners will be excluded from this study.
  5. Subjects are over 60 or have any suspicion of abnormal kidney function (a blood test to determine Glomerular filtration rate (GFR) will be performed prior to imaging. Subjects with GFR<30 will be excluded from the study. This is standard practice for clinical scans in Radiology due to the extremely small but not negligible relationship between gadolinium contrast agent and nephrogenic systemic fibrosis in patients with severely impaired renal function.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01710254

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Principal Investigator: Christopher J McGann, MD University of Utah
  More Information

S. E. Litwin, J. Fluckiger, L. Chen, T. H. Kim, N. Pack, B. Matthews, C. McGann, R. Jiji, et al. Does fixed-dose regadenoson induce comparable myocarial perfusion reserve in patients of widely varying body size? A quantitative MRI study. American Heart Association, chicago, 2010.
O. J. Booker, P. Bandettini, P. Kellman, J. Wilson, S. Leung, S. Vasu, S. Shanbhag, J. Henry, et al. Time resolved measure of coronary sinus flow following regadenoson administration. Journal of cardiovascular magnetic resonance, 13(1): O74, 2011.

Responsible Party: Brent Wilson, Associate Professor, University of Utah Identifier: NCT01710254     History of Changes
Other Study ID Numbers: REGA-12F08
Study First Received: October 2, 2012
Last Updated: November 1, 2016

Keywords provided by University of Utah:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 28, 2017