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

Phase 2

Withdrawn

• Conditions: Stable Angina Pectoris
• Interventions: Procedure: Percutaneous coronary angioplasty (PCI)

• Registration Number: NCT00825604
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With PCI	Percutaneous coronary angioplasty (PCI)	optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI)

Primary Outcome Measures

Name	Time	Method
Quality of life measured by SF36	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sahlgrenska University hospital; 🇸🇪 Göteborg, Sweden