NCT01053975终止不适用
SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
Spirocor26 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2010年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,000
- 试验地点
- 26
- 主要终点
- RSR vs. S-ECG in subjects suspected with S-CAD
研究概览
简要总结
The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject with suspected S-CAD
- •Subject able to perform the guided breathing protocol and comply with study requirements
- •Subject is able and agrees to sign the informed consent form
排除标准
- •Resting (supine) ECG evidence of ST-segment depression ≥ 1 mm in any lead or left bundle branch block or significant arrhythmia
- •Current digoxin therapy
- •Subject has severe valvular heart disease
- •Subject has congestive heart failure NYHA class III/IV
- •Subject has known history of myocardial infarction (ST elevation or non ST elevation)
- •Subject had previous coronary revascularization: CABG or PCI
- •Subject has pacemaker or ICD that controls sinus
- •Morbidly obese subject (BMI ≥ 40)
- •Subject has any significant medical condition which, at the investigator's discretion, may interfere with the subject's optimal participation in the study; and
- •Subject is currently participating in another investigational product clinical study that the investigator believes may interfere with the outcome of this study
结局指标
主要结局
RSR vs. S-ECG in subjects suspected with S-CAD
时间窗: 3 weeks window
次要结局
未报告次要终点
研究者
研究点 (26)
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