CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Regadenoson +1 moredrug
Likely dose
Regadenoson 0.4 mgfrom 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/NCT01655043
NCT01655043Phase 2Completed

Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI

Northwestern University·interventional·Posted Aug 1, 2012·Updated Aug 28, 2019

In Brief

A Phase 2 clinical trial evaluating Regadenoson and gadofoveset trisodium for Myocardial Ischemia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images. In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy. The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 1, 2012
Enrollment StartSep 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.9 years ago

Interventions

Regadenosondrug

Regadenoson will be infused intravenously 0.4 mg/5 mL (0.08 mg/mL) as a single bolus.

gadofoveset trisodiumdrug

All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar) at both stress and rest.