Prospective Multicenter Pilot Observational Study Evaluating the Diagnostic Performance of the HeartBeam 3-Lead ECG System in Detecting Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the HeartBeam ECG for detection of ACS
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic performance of the HeartBeam ECG System for detection of acute coronary syndrome. The study will enroll adults who come to the emergency department with chest pain or other symptoms suggestive of ACS. Participants will take the HeartBeam ECG recording within minutes of standard 12-lead ECG.
详细描述
The primary objective of the ALIGN-ACS pilot study is to obtain preliminary estimates of the diagnostic performance (sensitivity and specificity) of the HeartBeam 3-lead ECG System for detecting ACS, relative to an adjudicated gold-standard diagnosis, with the standard 12-lead ECG as comparator.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 years of age and older.
- •All-comers to the hospital ED with the symptoms of chest pain and an ECG taken on admission are considered for ACS evaluation.
- •Able and willing to sign ICF.
排除标准
- •Open chest wounds or recent (<30 days) surgery of the chest or abdomen.
- •Clinical conditions that, in the opinion of the Investigator, would compromise the patient's safety or ability to complete the protocol.
结局指标
主要结局
Sensitivity and specificity of the HeartBeam ECG for detection of ACS
时间窗: 1 day - acute recording from ED
Sensitivity and specificity of the HeartBeam ECG System for detection of ACS, reported as point estimates with 95% confidence intervals, adjudicated against the gold-standard diagnosis.
次要结局
未报告次要终点