Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Stable Angina Pectoris

Intervention / Treatment
-----------------
* Procedure: Percutaneous coronary angioplasty (PCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without PCI<br>Optimized medical treatment, physical training and smoking cessation | |
| Active Comparator: With PCI<br>optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI) | Procedure: Percutaneous coronary angioplasty (PCI)<br>* optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):<br>* Other names: PCI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured by SF36 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stable coronary artery disease, quality of life, target achievement, physical training, percutaneous coronary intervention