CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Regadenoson MRI +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01710254
NCT01710254Phase 2Completed
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Detection of Coronary Artery Disease in Patients With Atrial Fibrillation Using Regadenoson Stress MRI

University of Utah·interventional·Posted Oct 19, 2012·Updated Dec 13, 2017

In Brief

A Phase 2 clinical trial evaluating Regadenoson MRI and Gadobenate dimeglumine for Atrial Fibrillation and Coronary Artery Disease. Completed, enrolled 30 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Coronary Artery Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2012
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.7 years ago

Interventions

Regadenoson MRIdrug

AF patients will be provided with a regadenoson stress MRI to see if coronary artery disease can be detected with more sensitivity /specificity.

Gadobenate dimegluminedrug

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.