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临床试验/NCT07419139
NCT07419139尚未招募不适用

Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation

Leipzig Heart Science gGmbH0 个研究点目标入组 304 人开始时间: 2026年4月1日最近更新:

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

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

研究者

发起方
Leipzig Heart Science gGmbH
申办方类型
Other
责任方
Sponsor

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