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临床试验/NCT00391326
NCT00391326已完成不适用

Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients Redirected for Primary PCI Based on Tele-Transmitted 12-Lead ECGs

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2006年11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
102
试验地点
2

研究概览

简要总结

The purpose of this study is to describe the efficacy and safety of prehospital administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial infarction redirected for primary angioplasty bypassing local hospitals, immediately after the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.

详细描述

Primary angioplasty (pPCI) is the therapy of choice in patients with ST elevation acute myocardial infarction (STEMI) in Denmark. However, time is lost transferring patients from a local hospital to an invasive treatment centre. Time can be saved by redirecting STEMI patients to pPCI based on wireless prehospital 12-lead electrocardiogram (ECG) transmission directly to a cardiologist's handheld device. To prevent complications during the transportation of STEMI patients to the invasive hospital, patients are treated with oxygen, aspirin, clopidogrel, heparin, and nitro-glycerine in the ambulance. However, heparin use is cumbersome for the ambulance personnel since it must be kept at 5 degrees Celsius. An alternative to heparin may be bivalirudin, since it can be kept at room temperature and thus is easily administered in the prehospital setting.

Comparison: Heparin versus bivalirudin treatment. Efficacy is determined by thrombolysis in myocardial infarction (TIMI) flow in the first and final coronary angiogram. Safety is determined by the rate of bleeding complication.

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

性别
All
接受健康志愿者

入选标准

  • ST elevation acute myocardial infarction patients redirected for primary angioplasty
  • Symptoms less than 12 hours

排除标准

  • Contraindications against primary angioplasty

研究者

申办方类型
Other

研究点 (2)

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