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临床试验/NCT01334645
NCT01334645已完成不适用

Diagnostic Value of Copeptin Assay for Acute Coronary Syndrome Without ST-segment Elevation

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
2
主要终点
Copeptin value

研究概览

简要总结

The purpose of this study is to determine whether the combination of copeptine and troponin adds diagnosis information to that provided by troponin alone or the combination of troponin and myoglobin.

Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute myocardial infarction can be ruled out without prolonged monitoring and serial blood sampling.

详细描述

Patients older than 18 years with pain suggestive of Acute Coronary Syndrome, with onset within the last 12 hours, presenting to the Emergency Department of the University Hospital Gabriel Montpied (Clermont-Ferrand, France) and the General Hospital Henri Mondor (Aurillac, France) are enrolled.

Upon admission to the hospital, all patient underwent an initial clinical assessment, including medical history, temperature, respiratory rate, cardiac frequency, blood pressure, pulse oxymetry, 18-lead ECG, chest X-ray and screening blood test including C reactive protein, natremia, Troponine T, myoglobin, creatin kinase and copeptine.

Patients with hyponatremia < 135 mmol/L or troponin > 1 μg/L are released study.

Blood sampling are taken for Troponine T, myoglobin, creatin kinase and copeptine analysis and 18-lead ECG was performed after 2, 4, 6 and 12 h.

Copeptin and myoglobin are measured at the end of the patients inclusion, after to be centrifugrd end frozen at -80°C at each time point.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Participant)

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

  • Chest pain suggestive of Acute Coronary Syndrome
  • Chest pain with onset within the last 12 h
  • Patients older than 18 years

排除标准

  • ST-Elevation Myocardial infarction
  • Legal incapacity
  • Hyponatremia < 135 mmol/L
  • Lung neoplasms
  • life expectancy of less than 6 months
  • Refuse to consent

结局指标

主要结局

Copeptin value

时间窗: at day 1

次要结局

  • Troponin, Myoglobin and Creatin Kinase values. Clinicals and paraclinicals events .(at 90 days)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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