Stable Angina Pectoris
Conditions
Keywords
stable coronary artery disease, quality of life, target achievement, physical training, percutaneous coronary intervention
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPercutaneous coronary angioplasty (PCI)
optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):
Sponsors
Sahlgrenska University Hospital
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life measured by SF36 | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed