Document Detail


The RegEx trial: a randomized, double-blind, placebo- and active-controlled pilot study combining regadenoson, a selective A(2A) adenosine agonist, with low-level exercise, in patients undergoing myocardial perfusion imaging.
MedLine Citation:
PMID:  19152130     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Although vasodilator stress myocardial perfusion imaging (MPI) is increasingly performed with exercise, adenosine A(2A) receptor agonists have not been studied with exercise. OBJECTIVES: To determine the safety of administering regadenoson during exercise and, secondarily, to evaluate image quality, patient acceptance, and detection of perfusion defects. METHODS: Patients requiring pharmacologic MPI received a standard adenosine-supine protocol (AdenoSup, n = 60) and were then randomized (2:1) in a double-blind manner to low-level exercise with bolus intravenous injection of regadenoson (RegEx, n = 39) or placebo (PlcEx, n = 21). RESULTS: Adverse events occurred in 95%, 77%, and 33% of patients receiving AdenoSup, RegEx, and PlcEx, respectively. Peak heart rate was 13 beats per minute (bpm) and 21 bpm greater following RegEx compared to that following PlcEx and AdenoSup, respectively (P = .006 and <.001). Change from baseline in mean systolic blood pressure (SBP), change from baseline to nadir SBP, and percentage of patients with a decline in SBP by > or = 20 mm Hg showed no important differences between RegEx and PlcEx. No occurrences of 2nd degree or higher AV block were observed following RegEx or PlcEx; one patient developed 2nd degree AV block following AdenoSup. The mean heart-to-liver and heart-to-gut ratios were improved on RegEx vs AdenoSup: 0.85 (0.34) vs 0.65 (0.26), P < .001 and 1.1 (0.36) vs 0.97 (0.34), P < .001, respectively. Compared to AdenoSup, 70% of patients felt RegEx was much or somewhat better. CONCLUSIONS: Combining regadenoson with low-level exercise is feasible, well tolerated, and associated with fewer side effects compared to AdenoSup.
Authors:
Gregory S Thomas; Randall C Thompson; Michael I Miyamoto; Tze K Ip; Deborah L Rice; Douglas Milikien; Hsiao D Lieu; Vandana S Mathur
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-01-20
Journal Detail:
Title:  Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology     Volume:  16     ISSN:  1532-6551     ISO Abbreviation:  J Nucl Cardiol     Publication Date:    2009 Jan-Feb
Date Detail:
Created Date:  2009-01-19     Completed Date:  2009-07-09     Revised Date:  2010-04-12    
Medline Journal Info:
Nlm Unique ID:  9423534     Medline TA:  J Nucl Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  63-72     Citation Subset:  IM    
Affiliation:
Cardiology Division, Mission Internal Medical Group, 26800 Crown Valley Pkwy, Suite 120, Mission Viejo, CA 92691-6331, USA. gthomas@mimg.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Exercise Test*
Feasibility Studies
Female
Humans
Purines / diagnostic use*
Pyrazoles / diagnostic use*
Radiopharmaceuticals / diagnostic use
Receptor, Adenosine A2A / antagonists & inhibitors*
Reproducibility of Results
Sensitivity and Specificity
Technetium Tc 99m Sestamibi / diagnostic use*
Ventricular Dysfunction, Left / radionuclide imaging*
Chemical
Reg. No./Substance:
0/Purines; 0/Pyrazoles; 0/Radiopharmaceuticals; 0/Receptor, Adenosine A2A; 0/regadenoson; 109581-73-9/Technetium Tc 99m Sestamibi

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