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临床试验/NCT02608255
NCT02608255已完成不适用

A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1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
100
试验地点
2
主要终点
blood sample : dosage of CD26

研究概览

简要总结

A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic.

All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.

详细描述

First objectives: demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Subject with compatible symptoms with an acute coronary syndrome, for at least 15 minutes and not older than 3 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or two arms, pain in the jaw, pain in the back / neck / stomach, breathlessness , cold sweats, nausea / vomiting , dizziness )
  • Man or woman,
  • Patient Did not receive heparin or low molecular weight heparin (LMWH ) before the initial blood sample ,
  • Patient Agreeing to participate in the study and who signed an informed consent

排除标准

  • Minor or major patient trust
  • Patient Not having signed informed consent (refusal , physical or mental disability ... )
  • Patient Who received anticoagulation before carrying blood samples
  • Patient With a progressive septic processes , neoplasia undergoing treatment, dialyzed kidney failure, a history of surgery or coronary angioplasty less than six months.
  • Transplanted heart, renal or hepatic
  • heart attack
  • Subject Whose symptoms clearly eliminates acute coronary syndrome ( penetrating trauma, traumatic injury by crushing ... )
  • Patient Died between the time of inclusion and arrival in the cardiology intensive care ( SIC )
  • Patient Withdrawing consent under study

结局指标

主要结局

blood sample : dosage of CD26

时间窗: 12 MONTHS

demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.

blood sample: dosage of the copeptin

时间窗: 12 months

blood sample: dosage of troponin

时间窗: 12 months

blood sample : dosage of IMA

时间窗: 12 months

IMA (Albumin modified by the ischaemia)

blood sample: dosage of adenosin

时间窗: 12months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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