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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
Results First Submitted: October 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Atrial Fibrillation
Coronary Artery Disease
Interventions: Drug: Regadenoson MRI
Drug: Gadobenate dimeglumine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Regadenoson MRI Participants with atrial fibrillation receiving regadenoson stress MRI

Participant Flow:   Overall Study
    Regadenoson MRI
STARTED   30 
COMPLETED   30 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Regadenoson MRI Participants with atrial fibrillation receiving regadenoson stress MRI

Baseline Measures
   Regadenoson MRI 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  26.7% 
>=65 years      22  73.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (13.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  43.3% 
Male      17  56.7% 


  Outcome Measures
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1.  Primary:   Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)   [ Time Frame: one MRI, up to 1 hour ]

2.  Primary:   Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)   [ Time Frame: one MRI, up to 1 hour ]

3.  Secondary:   Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)   [ Time Frame: one MRI, up to 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Edward DiBella, Ph.D.
Organization: University of Utah, Dept. of Radiology Research
phone: 801-585-5543
e-mail: edward.dibella@hsc.utah.edu


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, 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