Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 9
- 主要终点
- Exercise Time on Treadmill
研究概览
简要总结
In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.
详细描述
The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation
排除标准
- •Acute coronary syndrome
- •Previous coronary artery bypass graft surgery
- •Left main stem disease
- •Contraindications to PCI or drug-eluting stent (DES) implantation
- •Heavily calcified or tortuous vessels
- •Chronic total occlusion in target vessel
- •Life expectancy <2yr
- •Pregnancy
- •Age <18yr or >85yr
- •Angiographic stenosis ≥ 50% in non-target vessel
- •Inability to consent
结局指标
主要结局
Exercise Time on Treadmill
时间窗: 6 weeks
Measured in seconds on Modified Bruce exercise treadmill protocol
次要结局
未报告次要终点