Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate
研究概览
简要总结
This is a prospective, multi-center study to capture information on sensitivity and specificity of CADence using coronary angiogram as the gold standard, on subjects who are already scheduled for coronary angiography.
详细描述
CADence is an ECG and acoustic tool to assess coronary artery disease. This study's goal is to collect patient CADence information and compare it to the results of angiogram to determine performance: sensitivity and specificity. The CADence is not used to direct patient care. This is observational only.
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
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >40 years
- •Clinical indication for coronary angiogram
- •Willing and able to give informed consent
排除标准
- •Body Mass Index (BMI) <18.5 or >40
- •Prior bypass surgery or coronary stenting
- •Presence of pacemaker/defibrillator
- •Presence of artificial valve
- •Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta
- •Presence of murmurs, including valve lesions, ventricular septal defects and arteriovenous fistulae
- •Presence of moderate-severe valve disease
- •Left Ventricular Assist Device (LVAD)
- •Presence of scars on the site thorax areas
- •Participation in trial within 30 days prior to collecting CADence data except participation in registry studies.
- •Asthma or chronic obstructive pulmonary disease (COPD) with active wheezing
- •Inability to lie in supine position
- •Heart Transplant
结局指标
主要结局
Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate
时间窗: 24 hours or discharge from hospital, whichever is sooner
Angiographically significant stenosis was defined as 70% or greater stenosis in any major coronary artery. Percent of Participants with Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as accurate and appropriate. The study is used to determine two conditions. CADence = Positive for 70% or greater stenosis and CADence = Negative for less than 70% stenosis. The pre-specified intent of this Outcome Measure was to assess all study participants combined, irrespective of whether or not they participated in the Ambience main study or the repeatability and reproducibility sub-study.
次要结局
- Number of Participants With CADence-related Adverse Events(24 hours or discharge from hospital, whichever is sooner)