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

NCT01021618 | Completed Results

• 1 other identifier: HELL002965HI
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Myocardial Perfusion Image Quality

  0 hours

Study Arms (2)

Vasodilator-exercise stress

ACTIVE COMPARATOR

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

Exercise-vasodilator stress

EXPERIMENTAL

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.

Drug: Regadenoson

Interventions

Regadenoson DRUG

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

Also known as: Lexiscan, Exercise-lexiscan stress test

Exercise-vasodilator stress

Symptom-limited exercise OTHER

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

Also known as: Persantine, Persantine-exercise stress test

Vasodilator-exercise stress

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise
• Age \>=30 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (3)

• 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.

  PMID: 8254386 BACKGROUND

• 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.

  PMID: 18242479 BACKGROUND

• 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.

  PMID: 19152130 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

regadenoson; Dipyridamole

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gary V Heller, MD, PhD
• Organization: Hartford Hospital

aahlber@harthosp.org

860-545-5527

Study Officials

• Gary V Heller, MD, PhD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 21, 2013
• Results First Posted: December 28, 2012

Record last verified: 2013-03

Locations

US (1)