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临床试验/NCT00260416
NCT00260416已完成2 期

Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours

Aarhus University Hospital Skejby2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).

研究概览

简要总结

Background: Acute balloon angioplasty is beneficial in patients with acute myocardial infarction. However, presently this treatment is not offered to patients with symptom duration above 12 hours.

Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom duration above 12 hours.

Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long symptom duration.

详细描述

Methods: On arrival at our angioplasty laboratory, patients are informed about the study. If they accept to participate, we infuse 600 MBq of Sestamibi i.v. This binds in a first passage fashion without later redistribution to perfused myocardium. Non-perfused myocardium does not bind sestamibi. Primary angioplasty with stent and abciximab is then performed followed by myocardial scintigraphy to illustrate the non-perfused myocardial area that was at risk of infarction before the coronary artery was opened. Echocardiography is also performed. At 1 month, myocardial scintigraphy is repeated to evaluate infarct size. The difference between the myocardial area at risk of infarction before angioplasty and the myocardial infarct size 1 month later is defined as "salvage". Scintigraphy is repeated at 6 month and echocardiography is also repeated at 1 month and 6 months. The primary endpoint is "salvage". Accordingly, the aim is to demonstrate that salvage can be achieved with primary angioplasty for acute myocardial infarction despite symptom duration above 12 hours. Clinical endpoints are death and reinfarction. The results are compared with results in 200 patients with symptom duration below 12 hours. These patients are treated and examined according to the exact same protocol. By this comparison, it can be evaluated whether it is relevant that the current guidelines recommend acute balloon angioplasty only to patients with less than 12 hours of symptom duration.

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
Treatment
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

  • Acute myocardial infarction with ST-segment elevation;
  • Symptom duration 12 hours to 72 hours.

排除标准

  • Age below 18 years;
  • Bleeding disorders or anaemia or low levels of thrombocytes;
  • Thrombolysis used during the present admission;
  • Expected survival less than 1 year due to other diseases;
  • Previous acute myocardial infarction or coronary by-pass surgery;
  • Major operation within last 30 days;
  • Heamorrhaghic stroke within last 3 months.

结局指标

主要结局

Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).

次要结局

  • Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
  • Death at 1 month and 6 months.
  • Reinfarction at 1 month and 6 months.
  • Ejection fraction at 1 day, 1 month and 6 months.
  • Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
  • Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.

研究者

发起方
Aarhus University Hospital Skejby
申办方类型
Other

研究点 (2)

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