跳至主要内容
临床试验/NCT02116153
NCT02116153Unknown不适用

Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED

University Hospital Heidelberg0 个研究点开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
主要终点
Death

研究概览

简要总结

Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients admitted to the emergency department ("chest pain unit"), Dept. of Cardiology, University Hospital Heidelberg
  • Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain
  • Age >= 18 years
  • Written informed consent

排除标准

  • Mental disorders, dementia
  • Pregnancy, breast feeding
  • Age < 18 years

结局指标

主要结局

Death

时间窗: 90 days

次要结局

  • Myocardial Infraction(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Hugo Katus

Director, Department of Cardiology

University Hospital Heidelberg

相似试验