CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Regadenosondrug
Likely dose
Regadenoson 400 microgramsfrom 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/NCT01779869
NCT01779869Phase 4Completed

Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

Washington University School of Medicine·interventional·Posted Jan 30, 2013·Updated Jun 15, 2018

In Brief

A Phase 4 clinical trial evaluating Regadenoson for Ischemic Heart Disease. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The objective for this pilot study is to develop an optimized, clinically usable myocardial PET-MR perfusion protocol and to determine which of all data potentially available should be acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion imaging, significantly decreasing examination time and patient radiation dose while maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage. The primary outcome will be comparison of diagnostic accuracy of each combination of imaging to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).

Study Details

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

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2013
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.4 years ago

Interventions

Regadenosondrug

Regadenoson 400 micrograms will be administered in a single IV bolus (\<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.