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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Christopher McGann, University of Utah
ClinicalTrials.gov Identifier:
NCT01710254
First received: October 2, 2012
Last updated: January 23, 2014
Last verified: January 2014
  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
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 32
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)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710254

Contacts
Contact: Christopher J McGann, MD 8015852341 chris.mcgann@hsc.utah.edu
Contact: Lisa Dubler, CCRC 8015878190 Lisa.Dubler@hsc.utah.edu

Locations
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         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Christopher J McGann, MD University of Utah
  More Information

Publications:

Responsible Party: Christopher McGann, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01710254     History of Changes
Other Study ID Numbers: REGA-12F08
Study First Received: October 2, 2012
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
MRI
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on September 16, 2014