Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 304
- 主要终点
- Hospital-confirmed myocardial infarction
研究概览
简要总结
The PREDICT calibration study is a prospective, non-interventional trial aiming to adapt and calibrate the ACS-Pathfinder algorithm for prehospital triage of patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) in Germany. Approximately 304 patients will be enrolled by six emergency medical service (EMS) stations. All patients will receive standard care and an additional point-of-care troponin test (POCT) performed in the ambulance. Clinical and biomarker data will be collected using a study app, without influencing patient management. Follow-up will be conducted up to 90 days through telephone interviews and hospital record review.
The primary objective is to determine the true prevalence of myocardial infarction and calibrate the ACS-Pathfinder algorithm accordingly. Secondary objectives include assessing feasibility, workflow, acceptance, and data processes within the EMS as preparation for a subsequent cluster-randomized main study.
The study is coordinated by Prof. Holger Thiele (Heart Center Leipzig) with co-investigators from Leipzig and Hamburg. The sponsor is Leipzig Heart Science gGmbH. Study duration is planned from January to November 2026.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Suspected myocardial infarction
- •Symptom onset >30 minutes before arrival of emergency medical services
- •Written informed consent
排除标准
- •STEMI on initial ECG
- •Unstable angina, hemodynamic instability, life-threatening arrhythmias, cardiac arrest
- •Non-ischemic causes requiring hospitalization
- •Emergency physician dispatch at the request of a primary care physician
- •Age <18 years
结局指标
主要结局
Hospital-confirmed myocardial infarction
时间窗: from March 2026 to Jun 2026
The primary endpoint is hospital-confirmed myocardial infarction in patients referred to the PREDICT calibration study by emergency medical services with suspected acute coronary syndrome (ACS).
次要结局
未报告次要终点
