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临床试验/NCT02116426
NCT02116426已完成不适用

The Role of Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2015年7月29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
320
试验地点
2
主要终点
Blood copeptin concentration (pmol/l)

研究概览

简要总结

The main objective of our study is to evaluate the diagnostic value of copeptin testing in association with troponin HS testing during pre-hospital care (ambulance care) in the treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS but not ST+.

详细描述

The secondary objectives of this study are to:

A. Evaluate the diagnostic value of determination of copeptin testing in pre-hospital care in another diagnosis;

B. Assess the prognostic value of copeptin assay on vital prognosis at day 28;

C. Evaluate the kinetics of copeptin and troponin HS between initial ambulance care and arrival at the emergency department;

D. Evaluate the potential impact of copeptin testing on pre-hospital patient care;

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

入选标准

  • all major adult patients taken in charge by the emergency ambulance services of the participating centers for non-traumatic chest pain for suspected ACS and an electrocardiogram initially excluding an ST segment elevation

排除标准

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient (or a legal representative) formalizes his/her opposition for the study
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has a contraindication for a treatment used in this study
  • The patient's initial electrocardiogram indicates an ST segment elevation

结局指标

主要结局

Blood copeptin concentration (pmol/l)

时间窗: Day 0, in the ambulance

Final diagnosis of ACS non ST + (yes/no)

时间窗: Day 28

Blood troponin HS concentration (µg/L)

时间窗: Day 0, in the ambulance

次要结局

  • Blood troponin HS concentration (µg/L)(Day 0, 3 hours after arrival in the emergency department)
  • Time spent by ambulance staff at the patient's place of residence(Day 0)
  • Distance (km) between the hospital and the patient's place of residence(Day 28)
  • Would you leave the patient at home if both copeptin and troponin tests were negative?(Day O (in the ambulance))
  • Hospital costs (€) associated with avoidable services(Day 28)
  • Mortality(Day 28)
  • Presence/absence of another diagnosis(Day 28)
  • Number of patients taken in charge that day by ambulance staff.(Day 0)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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