Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging
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|ClinicalTrials.gov Identifier: NCT01021618|
Recruitment Status : Completed
First Posted : November 30, 2009
Results First Posted : December 28, 2012
Last Update Posted : March 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia||Drug: Regadenoson Other: Symptom-limited exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Ex-Lex Trial: A Randomized Trial Combining Regadenoson With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: Vasodilator-exercise stress
Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise; injection of technetium-99m labeled radiopharmaceutical at peak hyperemia or peak exercise followed by SPECT myocardial perfusion imaging
Other: Symptom-limited exercise
Dipyridamole (0.56 mg/kg) over 4 minutes followed by symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging
Experimental: Exercise-vasodilator stress
Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) in patients failing to achieve a standard clinical endpoint; injection of technetium-99m labeled radiopharmaceutical 15 seconds after administration of regadenoson (or at peak exercise if regadenoson not administered) followed by SPECT myocardial perfusion imaging.
Regadenoson (0.4mg/5 mL) injection during symptom-limited exercise with technetium-99m SPECT myocardial perfusion imaging
- Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire [ Time Frame: 24 hours ]Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as "severe" by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.
- Myocardial Perfusion Image Quality [ Time Frame: 0 hours ]Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021618
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|Principal Investigator:||Gary V Heller, MD, PhD||Hartford Hospital|