NCT03546933终止不适用
A Prospective Multi-centre Observational Study to Validate the Diagnostic Accuracy of a Transportable Magnetocardiograph Device for Acute Coronary Syndrome (ACS), Focusing on Rule-out Capability, in Patients Who Present to the Emergency Department With Chest Pain Symptoms Consistent With ACS
Creavo Medical Technologies Ltd5 个研究点 分布在 1 个国家目标入组 651 人开始时间: 2018年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 651
- 试验地点
- 5
- 主要终点
- Sensitivity and specificity of MCG
研究概览
简要总结
A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.
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
- •Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
- •18+ year old male or female
- •Patient is willing and able to give written informed consent
排除标准
- •ST-segment Elevation MI (STEMI)
- •Clear non-ischemic cause for symptoms (e.g. trauma)
- •Hemodynamic instability on admission (e.g. BP>220mmHg systolic & >110mmHg diastolic, <80mmHg systolic & <40mmHg diastolic, HR>160bpm)
- •Ventricular tachycardia or fibrillation that cannot be treated effectively
- •Atrial fibrillation
- •Thoracic metal implants
- •Pacemaker or internal defibrillator
- •Pregnancy (if after 20-week period)* or lactation
- •Patient unable to lie down (i.e. supine position) or stay still on the examination bed
- •Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English- speaking relative/translator not available)
- •Patient unable to comply with the requirements of the protocol
结局指标
主要结局
Sensitivity and specificity of MCG
时间窗: up to 3 month follow-up
Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm
次要结局
- 3.Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups(up to 3 months follow-up)
- MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses))(through 1 week, 3 month follow-up)
- Proportion of adverse events and types(up to 3 month follow-up)
- All-cause mortatility (divided into CV and non-CV causes) proportion(through 1 week, 3 month follow-up)
研究者
研究点 (5)
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