NCT00907764终止2 期
An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent.
研究概览
简要总结
Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress
- •Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress
排除标准
- •Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography
- •Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
研究组 & 干预措施
Regadenoson alone
Experimental
干预措施: regadenoson (Drug)
Regadenoson with exercise
Experimental
干预措施: regadenoson (Drug)
Regadenoson with contrast agent
Experimental
干预措施: regadenoson (Drug)
Regadenoson with contrast agent (perfusion)
Experimental
干预措施: regadenoson (Drug)
结局指标
主要结局
Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent.
时间窗: Within 12 minutes after dosing
次要结局
- Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications.(Up to day 29 after dosing)
研究者
研究点 (1)
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