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临床试验/NCT00000478
NCT00000478已完成3 期

Asymptomatic Cardiac Ischemia Pilot (ACIP) Study

National Heart, Lung, and Blood Institute (NHLBI)0 个研究点开始时间: 1990年11月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成

研究概览

简要总结

To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.

详细描述

BACKGROUND:

Asymptomatic cardiac ischemia, frequently designated as silent myocardial ischemia, refers to episodes of objectively demonstrable transient ischemia in the absence of symptoms. Annually, more than one million patients suffer acute myocardial infarction. Of the approximately 700,000 who are discharged alive from the hospital, as many as 180,000 will be asymptomatic but have evidence of myocardial ischemia on a pre-discharge exercise test. Asymptomatic ischemia has been linked with sudden death or myocardial infarction. It is estimated that in the United States over six million patients have chronic, symptomatic coronary heart disease and up to three million of these may exhibit transient asymptomatic myocardial ischemia. Asymptomatic ischemia is thought to be present in the majority of coronary heart disease patients with stable angina pectoris, over 70 percent of all ischemic episodes being asymptomatic. Asymptomatic ischemia following myocardial infarction or in the presence of chronic stable angina may be associated with substantially increased morbidity and mortality

Traditionally, treatment of patients with coronary heart disease has been given for and guided by patients' symptoms. There was a growing trend toward recognizing asymptomatic cardiac ischemia and according it importance equal to that of symptomatic ischemia. Many physicians believed that suppression of asymptomatic ischemia in patients with coronary heart disease would reduce morbidity and mortality. This was leading to rapidly increasing and widespread applications of both medical and revascularization therapies.

In 1989, there was a lack of knowledge as to the relative efficacy of different treatment strategies to control asymptomatic cardiac ischemia. Given the estimated high prevalence of asymptomatic cardiac ischemia in patients with coronary heart disease and evidence of increased risk of untoward outcome, the public health problem was of sufficient magnitude to warrant a pilot study to determine to what extent asymptomatic ischemia could be controlled. If the pilot study demonstrated feasibility, a full-scale clinical trial would then be considered to evaluate the impact of effective treatment of asymptomatic ischemia on survival and cardiovascular morbidity in patients with coronary heart disease.

DESIGN NARRATIVE:

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

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