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临床试验/NCT00382421
NCT00382421已完成不适用

Swiss Interventional Study on Silent Ischemia (SWISSI 1)

Luzerner Kantonsspital2 个研究点 分布在 1 个国家开始时间: 1992年2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, unstable angina pectoris, and revascularization

研究概览

简要总结

There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

详细描述

Although there is still controversy regarding why ischemic episodes are symptomatic in some patients and completely asymptomatic in others, it is now widely accepted that silent ischemia, like symptomatic episodes, negatively affects prognosis. Silent ischemia may occur in totally asymptomatic patients without (type I) or with a history (type II) of an ischemic cardiac event and coexists with symptomatic episodes in many patients (type III). However, there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), i.e. silent ischemia type I, and, particularly, on a possible benefit of medical therapy in such patients. Reasons lie in the difficulty to identify such patients and their expected low event rates implying that large patient populations and/or long follow-up periods would be necessary to come to definite conclusions. Still, to address this problem, we perform SWISSI 1 which includes totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. They are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented silent myocardial ischemia type I
  • At least one cardiovascular risk factor

排除标准

  • History of cardiovascular disease

结局指标

主要结局

Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization

次要结局

  • Overall mortality
  • Cardiac death
  • Non-fatal myocardial infarction
  • Stable and unstable angina pectoris
  • Revascularization

研究者

申办方类型
Other

研究点 (2)

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