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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01710254
First Posted: October 19, 2012
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brent Wilson, University of Utah
  Purpose
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 Drug: Gadobenate dimeglumine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Brent Wilson, University of Utah:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
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, 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: Lexiscan
Drug: 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.
Other Names:
  • Gd-BOPTA
  • Multihance

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710254


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Brent Wilson, MD University of Utah
  More Information

Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brent Wilson, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01710254     History of Changes
Other Study ID Numbers: REGA-12F08
First Submitted: October 2, 2012
First Posted: October 19, 2012
Results First Submitted: October 11, 2017
Results First Posted: November 7, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017

Keywords provided by Brent Wilson, University of Utah:
MRI
Atrial Fibrillation

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