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
研究组 & 干预措施
PCI of CTO
Intervention: PCI of CTO (Chronic Total Occlusion Percutaneous Coronary Intervention) Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. CTO PCI patients will receive blinded clopidogrel 75 mg daily for 6 months.
干预措施: Chronic Total Occlusion Percutaneous Coronary Intervention (Procedure)
Sham Procedure
Intervention: Sham procedure Subjects will be blinded to randomization assignment using a combination of conscious sedation and sensory isolation (e.g., blindfold and noise isolation). Control subjects will only undergo a "Sham procedure", wherein they will undergo bilateral arterial access, without angiography or PCI being performed. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. Sham group will receive blinded placebo clopidogrel for 6 months.
干预措施: Sham Procedure (Procedure)
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)