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临床试验/NCT00387231
NCT00387231已完成不适用

Swiss Interventional Study on Silent Ischemia (SWISSI 2)

Luzerner Kantonsspital2 个研究点 分布在 1 个国家开始时间: 1991年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
试验地点
2
主要终点
Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization

研究概览

简要总结

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy on long-term outcome in patients with recent myocardial infarction and silent ischemia.

详细描述

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction (MI). Despite these consistent findings, there are almost no prospective data unequivocally documenting a benefit of antiischemic therapy on prognosis in patients with silent ischemia. There is some indirect evidence of a better outcome after repeat angioplasty for silent restenosis. In patients with a recent MI, the Asymptomatic Cardiac Ischemia Pilot study documented a short-term benefit of antiischemic drug therapy and angioplasty in patients with silent and symptomatic ischemic episodes. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the (SWISSI 2) study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy, each combined with secondary preventive advice, aspirin and statin therapy, on long-term outcome in patients with recent MI and an exercise test without symptoms but silent ischemia verified by stress imaging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recent myocardial infarction within last 3 months
  • Documented silent myocardial ischemia (type I)

排除标准

  • Symptomatic myocardial ischemia

结局指标

主要结局

Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization

次要结局

  • Overall mortality; Cardiac death; Non-fatal myocardial infarction; Symptom-driven revascularization.

研究者

申办方类型
Other

研究点 (2)

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