SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Greater improvement in disease-specific health status, as assessed by the 7-item Seattle Angina Questionnaire (SAQ) Summary Score (SAQ-7, an established measure of health status in patients with coronary artery disease)
研究概览
简要总结
Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.
Treatment:CTO PCI, as per standard clinical practice.
Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed.
Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term
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
- Double (Participant, Outcomes Assessor)
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
- •Age 18 years or greater
- •Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- •Referred for clinically-indicated CTO PCI
- •Optimal medical therapy (at least two anti-anginal medications at maximum tolerated doses, aspirin, and statin)
排除标准
- •Coexisting conditions that limit life expectancy to less than 6 months or that could affect a patient's compliance with the protocol
- •Recent (<7 days) acute myocardial infarction
- •Patient has no symptoms related to the CTO
- •Known allergy to aspirin or clopidogrel
- •Increased risk of bleeding (need for warfarin, oral Xa inhibitor, or thrombin inhibitor administration, recent [within 30 days] major bleed, known bleeding diathesis or coagulation disorder)
- •Positive pregnancy test or breast-feeding
- •Chronic kidney disease, defined as serum creatinine > 2.5 mg/dL
- •Severe peripheral arterial disease limiting exercise capacity
结局指标
主要结局
Greater improvement in disease-specific health status, as assessed by the 7-item Seattle Angina Questionnaire (SAQ) Summary Score (SAQ-7, an established measure of health status in patients with coronary artery disease)
时间窗: 1 month
次要结局
- Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term(6 months)
- Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis(6 months)
- Greater improvement in exercise capacity, as assessed by treadmill exercise stress(Prior to and 1 month after index procedure)
- Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D)(Baseline and 6 months)
- Favorable incremental cost-effectiveness ratio(Through study completion, an average of 6 months)
- Greater improvement in individual components of patients' health status, as assessed by the SAQ Physical Limitation, Angina Frequency, and Quality of Life domains of the SAQ-7 score(Baseline and 6 months)
- Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score(Baseline and 6 months)