Phase 2
N=30
Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients
Atrial Fibrillation · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01710254 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) — 80 Percentage of true positive cases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Regadenoson MRI (Drug); Gadobenate dimeglumine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) |
80 | — |
| PRIMARY Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) |
100 | — |
| SECONDARY Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD) |
96 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease who will undergo catheterization X-ray angiography
Exclusion Criteria
- 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.
- Patients with claustrophobia will also be excluded since MRI is conducted in a closed environment.
- Patients with contraindications to MRI (pacemaker, metal implants).
- Pregnant subjects (or women who may become pregnant), minors, and prisoners will be excluded from this study.
- 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.
Data sourced from ClinicalTrials.gov (NCT01710254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.