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

Göteborg University

Status and phase: Withdrawn; Phase 2

Conditions: Stable Angina Pectoris

Treatments: Procedure: Percutaneous coronary angioplasty (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00825604

Dnr: 056-08

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Without PCI

No Intervention group

Description:

Optimized medical treatment, physical training and smoking cessation

With PCI

Active Comparator group

Description:

optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI)

Treatment:

Procedure: Percutaneous coronary angioplasty (PCI)