Prehospital Point-of-Care High-Sensitivity Troponin I for Rule-Out of Acute Myocardial Infarction in Suspected Non-ST-Segment Elevation Acute Coronary Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events (MACE) within 30 days
研究概览
简要总结
People who call emergency medical services (EMS) with chest pain or other possible heart-related symptoms are often taken to hospital for further testing. However, only a small proportion of these patients are ultimately diagnosed with a serious heart condition such as a heart attack. This means that many patients undergo hospital transport and evaluation even though their risk is low.
In hospitals, a blood test called high-sensitivity cardiac troponin is commonly used to help diagnose or rule out heart attacks. It is not yet well established whether this type of test can be used safely and effectively earlier, in the prehospital setting.
This study will investigate whether it is feasible to measure high-sensitivity troponin in the ambulance and how well the test can identify patients at low risk of serious heart conditions. A small blood sample will be taken as part of routine care and analyzed using a portable device. The test result will not be used to guide treatment or decisions during the study.
The study will assess how well the test predicts heart-related events within 30 days and how practical it is to perform the test in real-life emergency settings. The results may help guide future research on how to improve early assessment and decision-making for patients with suspected heart disease.
详细描述
This is a prospective observational diagnostic accuracy and feasibility study conducted in the Central Denmark Region.
Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), without ST-segment elevation on the prehospital electrocardiogram, and managed with planned transport to hospital are eligible for inclusion.
During routine EMS assessment, a venous blood sample (<0.5 mL) is obtained and analyzed using a portable point-of-care device for measurement of high-sensitivity cardiac troponin I (hs-TnI). The measurement is performed according to manufacturer instructions and local procedures. Troponin values are recorded for research purposes only and are not used to guide clinical decision-making. EMS personnel are not provided with interpretation guidance or clinical thresholds for hs-TnI.
Clinical assessment, treatment, triage, and transport decisions follow standard regional protocols and are independent of study participation.
Clinical data are obtained from prehospital records and hospital electronic health records. Final diagnoses, including acute coronary syndrome, are determined based on standard clinical evaluation, including serial in-hospital troponin measurements and other diagnostic procedures as clinically indicated.
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
- •Age 18 years or older
- •Assessed by one of the participating EMS units equipped for POCT sampling
- •Presentation with symptoms suggestive of acute coronary syndrome
- •Planned transport to hospital for further evaluation
排除标准
- •ST-segment elevation on prehospital electrocardiogram
- •Clinical condition requiring immediate life-saving intervention precluding study procedures
- •Interhospital transport
- •Prior inclusion in the study within 30 days
研究组 & 干预措施
Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), in whom ST-segment elevation myocardial infarction (STEMI) is not identified on the prehospital electrocardiogram, and who are managed with planned transport to hospital for further evaluation. Patients undergo prehospital blood sampling for high-sensitivity cardiac troponin I (hs-TnI) measurement using a point-of-care device. Clinical management, triage, and transport decisions are not influenced by study participation or biomarker results.
干预措施: Prehospital high-sensitivity cardiac troponin I measurement (Diagnostic Test)
结局指标
主要结局
Major adverse cardiac events (MACE) within 30 days
时间窗: 30 days
Composite outcome including acute myocardial infarction, coronary revascularization, or cardiovascular death within 30 days of the index emergency medical services contact.
次要结局
- Final diagnosis of acute coronary syndrome(24 hours)
- All-cause 30-day mortality(30 days)
- Coronary revascularization within 30 days(30 days)
- Diagnostic performance of prehospital hs-TnI for acute coronary syndrome(24 hours)
- Diagnostic performance of prehospital hs-TnI for 30-day MACE(30 days)