CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
Regadenoson +2 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/NCT02597543
NCT02597543Phase 4Completed
CompareCT.gov

Stress Cardiac MRI Using Regadenoson for Evaluation of Nonspecific Allograft Dysfunction

Paul Kim·interventional·Posted Nov 5, 2015·Updated Aug 22, 2017

In Brief

A Phase 4 clinical trial evaluating Regadenoson, Gadolinium, and 1 other intervention for Heart Transplant and 2 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Transplant, Acute Graft Rejection, Chronic Graft Rejection
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 5, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 30, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago

Interventions

Regadenosondrug

For use in stress myocardial perfusion imaging.

Gadoliniumdrug

For use in both perfusion imaging and late gadolinium enhancement.

Cardiac MRIprocedure

Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.