Skip to main content
OpenTrials
Completed

NCT Number: NCT01021618

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regadenoson

Drug

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

Other names: Lexiscan, Exercise-lexiscan stress test

Symptom-limited exercise

Other

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

Other names: Persantine, Persantine-exercise stress test

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2009
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.