NCT01584622撤回不适用
Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 14
- 主要终点
- Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Over 18 years old
- •Willing and able to give informed consent
- •Indicated for angiography evaluation.
排除标准
- •Pregnant or nursing
- •Presence of pacemaker/defibrillator
- •Presence of artificial valve
- •Presence of severe valve disease
- •Presence of congenital heart defect
- •Left Ventricular Assist Device (LVAD)
- •Presence of a bypass graft
- •Presence of scars on the site thorax areas
- •Coarctation of the aorta
- •Participation in trial within 30 days prior to collecting CADenceTM data
- •Asthma with wheezing
- •Inability to lie flat in the supine position
- •Acute STEMI
- •Heart Transplant
- •Recent Cocaine Use
结局指标
主要结局
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
时间窗: within three months
The CADence System will be considered to have demonstrated effectiveness in detecting greater than or equal to 50% coronary artery stenosis anywhere in the coronary tree if the estimated sensitivity as compared to angiography is statistically higher than 70%.
次要结局
未报告次要终点
研究者
研究点 (14)
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