Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021618
• Other study ID #: HELL002965HI
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: March 18, 2013
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2013
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise

• Age >=30 years

Exclusion Criteria:

• Extremely limited functional capacity

• Age <30 years

• Unable or unwilling to provide informed consent

• Pregnant or nursing females

• Current use of methylxanthines within 12 hours of testing

• Current use of dipyridamole or aminophylline within 48 hours of testing

• Uncontrolled hypertension (>200 mmHg systolic/>120 mmHg diastolic)

• Known hypertrophic cardiomyopathy with obstruction or severe aortic stenosis

• Decompensated congestive heart failure

• History of sick sinus syndrome or > first degree atrioventricular block in the absence of a functioning pacemaker

• Asthma or other bronchospastic reactive airway disease

• History of percutaneous coronary intervention or coronary artery bypass grafting, or documented history of acute myocardial infarction or unstable angina within one week of testing

• Patients at risk for hypotensive reaction to regadenoson

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Regadenoson
Regadenoson (0.4mg/5 mL) injection during symptom-limited exercise with technetium-99m 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

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ahlberg AW, Baghdasarian SB, Athar H, Thompsen JP, Katten DM, Noble GL, Mamkin I, Shah AR, Leka IA, Heller GV. Symptom-limited exercise combined with dipyridamole stress: prognostic value in assessment of known or suspected coronary artery disease by use of gated SPECT imaging. J Nucl Cardiol. 2008 Jan-Feb;15(1):42-56. doi: 10.1016/j.nuclcard.2007.09.025. — View Citation

Ignaszewski AP, McCormick LX, Heslip PG, McEwan AJ, Humen DP. Safety and clinical utility of combined intravenous dipyridamole/symptom-limited exercise stress test with thallium-201 imaging in patients with known or suspected coronary artery disease. J Nucl Med. 1993 Dec;34(12):2053-61. — View Citation

Thomas GS, Thompson RC, Miyamoto MI, Ip TK, Rice DL, Milikien D, Lieu HD, Mathur VS. 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. J Nucl Cardiol. 2009 Jan-Feb;16(1):63-72. doi: 10.1007/s12350-008-9001-9. Epub 2009 Jan 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire	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.	24 hours	Yes
Secondary	Myocardial Perfusion Image Quality	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).	0 hours	No