The Ex-Lex Trial: A Randomized Trial Combining Regadenoson With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise
- •Age >=30 years
排除标准
- •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
研究组 & 干预措施
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
干预措施: Symptom-limited exercise (Other)
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.
干预措施: Regadenoson (Drug)
结局指标
主要结局
Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire
时间窗: 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.
次要结局
- Myocardial Perfusion Image Quality(0 hours)