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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Göteborg University

Current Primary Outcome: Quality of life measured by SF36 [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Achievement of target of treatment based on interview of the patients [ Time Frame: 6 months ]
  • Death, myocardial infarction, stroke or new revascularization [ Time Frame: 6 months, one year and five years after randomization ]
  • To assess expectations of treatment at inclusion and fulfilment of expectations [ Time Frame: 6 months ]
  • Quality of life measured by EQ5D and Seattle angina questionaire [ Time Frame: 6 months and 5 years ]
  • Health economy [ Time Frame: 6 months, one year and five years ]


Original Secondary Outcome:

Information By: Göteborg University

Dates:
Date Received: January 20, 2009
Date Started: January 2009
Date Completion:
Last Updated: March 16, 2012
Last Verified: March 2012