CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
Regadenoson +1 moredrug
Likely dose
Regadenoson 0.4mgfrom 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/NCT01021618
NCT01021618N/ACompleted

The Ex-Lex Trial: A Randomized Trial Combining Regadenoson With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

Hartford Hospital·interventional·Posted Nov 30, 2009·Updated Mar 21, 2013

In Brief

A clinical study evaluating Regadenoson and Symptom-limited exercise for Coronary Artery Disease and Myocardial Ischemia. Completed, enrolled 140 participants across 1 site.

Detailed Summary

Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected patients, protocols that combine exercise (either low-level or symptom-limited) with vasodilator stress agents have been found to be safe and effective in both identification of the presence and severity of CAD as well as risk stratification for adverse cardiac outcome. However, currently utilized combined stress protocols have drawbacks. Further refinement of combined stress protocols would potentially lead to more appropriate stress protocol selection for patients while enhancing laboratory efficiency. The purpose of this prospective, randomized study will be to evaluate the relative merits of combining regadenoson with symptom-limited exercise in patients clinically-referred for vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is a safe and feasible stress testing modality which is non-inferior to that which combines symptom-limited exercise with dipyridamole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2009
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.6 years ago

Interventions

Regadenosondrug

Regadenoson (0.4mg/5 mL) injection during symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging

Symptom-limited exerciseother

Dipyridamole (0.56 mg/kg) over 4 minutes followed by symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging