Clinical trial NCT00825604: Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stable Angina Pectoris
Keywords: stable coronary artery disease
quality of life
target achievement
physical training
percutaneous coronary intervention
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2009-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of life measured by SF36
timeFrame: 6 months
Secondary outcomes:
measure: Achievement of target of treatment based on interview of the patients
timeFrame: 6 months
measure: Death, myocardial infarction, stroke or new revascularization
timeFrame: 6 months, one year and five years after randomization
measure: To assess expectations of treatment at inclusion and fulfilment of expectations
timeFrame: 6 months
measure: Quality of life measured by EQ5D and Seattle angina questionaire
timeFrame: 6 months and 5 years
measure: Health economy
timeFrame: 6 months, one year and five years
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University hospital
Study officials:
affiliation: Göteborgs Universty
name: Lars Grip, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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