Quality of Life and Achievement of Target of Treatment After Optimized Medical Treatment, Physical Training and Smoking Cessation With or Without Percutaneous Coronary Intervention in Patients With Stable Angina Pectoris.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Quality of life measured by SF36
研究概览
简要总结
The purpose of this study is to, in patients with stable angina pectoris, assess the additional benefit of PCI on top of optimized medical treatment, physical training and smoking cessation with regard to quality of life, achievement of target of treatment and clinical events such as death, acute myocardial infarction, stroke and revascularization.
详细描述
Patients with stable angina pectoris with a significant coronary stenosis will be randomized to optimized medical treatment, physical training and smoking cessation or to optimized medical treatment, physical training, smoking cessation and complimentary treatment with PCI. All patients will be followed up at six months and at one and five years regarding symptoms, blood lipids, systemic blood pressure, physical training status, smoking habits, and maximal exercise ECG.
Achievement of target of treatment will be measured by questions regarding the patients' expectation of the treatment at baseline and at a 6 month follow-up. The questions at 6 months will be based on the interviews at inclusion. Furthermore quality of life will be measured with three different measuring instrument; SF-36 short form, Seattle Angina Questionnaire (SAQ), and EQ-5D. These instruments will be given to the patients at baseline, at six months and at the five year follow up.
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
- 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
- •Stable coronary artery disease
- •Angina pectoris with at least angina class 2 according to Canadian Cardiovascular Society (CCS)
- •Angiographic verified stenos in a native vessel
- •Accepted for PCI
排除标准
- •Instable coronary artery disease or AMI withín two months
- •CCS class IV
- •Stenosis in Left main and/or proximal LAD
- •NYHA- III-IV
- •Fall in blood pressure during exercise test > 10mm Hg, measured two times
- •Contraindication or allergy against clopidogrel or ASA
- •Unable to communicate verbal or i writing
- •Unwillingness to participate in the study
- •Participating in an other study
研究组 & 干预措施
Without PCI
Optimized medical treatment, physical training and smoking cessation
With PCI
optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI)
干预措施: Percutaneous coronary angioplasty (PCI) (Procedure)
结局指标
主要结局
Quality of life measured by SF36
时间窗: 6 months
次要结局
- Achievement of target of treatment based on interview of the patients(6 months)
- Death, myocardial infarction, stroke or new revascularization(6 months, one year and five years after randomization)
- To assess expectations of treatment at inclusion and fulfilment of expectations(6 months)
- Quality of life measured by EQ5D and Seattle angina questionaire(6 months and 5 years)
- Health economy(6 months, one year and five years)