Assessment in a Randomized Controlled Trial of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,664
- 试验地点
- 1
- 主要终点
- demonstrate the non-inferiority of a strategy of clinical follow-up
研究概览
简要总结
Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.
ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.
详细描述
Coronary artery revascularization is commonly used for the management strategy of patients with coronary artery disease (CAD).
In the following years after revascularization, the current guidelines recommend evaluation with stress tests when patients are symptomatic. Due to the lack of randomized trials, the evaluation of asymptomatic patients is controversial and accordingly there is a wide variation in routine follow-up strategies in these patients. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival We hypothesized that clinical follow-up alone would be non-inferior to systematic stress testing screening strategy during follow-up of asymptomatic CAD patients with prior coronary revascularization.
The primary objective of ARCACHON trial is to demonstrate the non-inferiority of a strategy of clinical follow-up (without non-invasive stress testing) in asymptomatic patients with a history of coronary revascularization compared to a strategy of systematic screening for myocardial ischemia using non-invasive stress testing by the primary endpoint as the composite of: all-cause death, myocardial infarction, stroke or any cardiovascular event leading to unplanned hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Prior coronary revascularization (PCI or CABG) at any time before randomization.
- •Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
- •Patient affiliated to Social Security
- •Informed, written consent from the patient
排除标准
- •Age < 18years
- •Any acute coronary syndrome in the previous 3 months
- •Symptoms suggestive of angina pectoris at the time of randomization:
- •Angina is characterized by ischemic chest pain occurring on exertion or stress relieved by rest and/or nitroglycerine.
- •Angina equivalents are defined as dyspnea, fatigue, or diaphoresis on exertion evaluated by the principal investigator as abnormal and attributable to myocardial ischemia.
- •Any severe valvular disease
- •Prior heart transplantation
- •Class III or IV symptomatic heart failure (NYHA classification).
- •Persons whose occupations impact on public safety (e.g. airline pilots, lorry or bus drivers) in whom systematic stress testing could be required for medico-legal reasons
- •Malignancies and other comorbid conditions with a life expectancy < 2 years
- •Pregnancy or nursing women
- •Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
- •Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden
- •Inability to sign an informed consent. Patient under legal protection (guardianship, curatorship) or mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
结局指标
主要结局
demonstrate the non-inferiority of a strategy of clinical follow-up
时间窗: minimum 24 months to 48 months
The primary outcomes measured at longest follow-up (minimum 24 months) the number of All-cause death in each arm
次要结局
- compare the clinical follow-up strategy to a systematic screening of myocardial ischemia(minimum 24 months to 48 months)