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临床试验/NCT02713048
NCT02713048已完成不适用

Sensitive Troponin I and Coronary Anatomy in Patients With Out-of-hospital Cardiac Arrest

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Peak Troponin I value

研究概览

简要总结

Troponin is a major diagnostic criterion of acute myocardial infarction (AMI) which confirms myocardial damage and necrosis. In out-of-hospital cardiac arrest (OHCA) patients its dynamics and diagnostic value is often controversial and has not been well described. Most of prior studies were retrospective, using first generation troponin assays and assessing only admission troponin. The aim of this work is to correlate dynamics of sensitive troponin I with urgent coronary angiography.

Patients resuscitated after OHCA will be prospectively divided in three groups based on the results of their urgent angiographies. Serial assessment of sensitive troponin I will be obtained over initial 48 hours.

We expect admission troponin will not be predictive of AMI. Over next hours troponin levels will be highest in patients with acute coronary lesion, lower in stable obstructive coronary disease and insignificant in non-obstructive coronary disease. We also expect significant difference in highest values and dynamics of troponin in sub-group with spontaneous reperfusion (TIMI flow 2 and 3) comparing to patients with coronary occlusion (TIMI flow 0 and 1). In patients with non-obstructive disease we expect troponin levels to correlate with duration of cardiac arrest, number of external electric shocks and cumulative dose of adrenaline administered.

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

  • female and male over 18 years old
  • comatose survivors after out-of-hospital cardiac arrest (OHCA)
  • absence of an obvious non-coronary cause
  • urgent coronary angiography at admittance
  • less than 3 hours from OHCA to first troponin assessment at admittance

排除标准

  • sub-acute myocardial infarction
  • coronary spasms or in-stent thrombosis within first 48 hours after admission
  • Coronary surgery or death within first 48 hours after admission

结局指标

主要结局

Peak Troponin I value

时间窗: Within 48 hours after hospital admission

Peak troponin I values will be compared among 3 groups with different coronary anatomy

次要结局

  • Peak troponin I value in acute coronary syndrome group(Within 48 hours after hospital admission)
  • Admission troponin I value(Within 3 hours of cardiac arrest)

研究者

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

Marko Noc

Marko Noc, MD, PhD

University Medical Centre Ljubljana

研究点 (1)

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