LOBSTR: Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Without PCI Optimized medical treatment, physical training and smoking cessation |
|
| Active Comparator: With PCI optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI) |
Procedure: Percutaneous coronary angioplasty (PCI)
optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Quality of life measured by SF36 [6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sahlgrenska University hospital | Göteborg | Sweden | 41345 |
Sponsors and Collaborators
- Göteborg University
- Sahlgrenska University Hospital, Sweden
Investigators
- Principal Investigator: Lars Grip, Prof., Göteborgs Universty
Study Documents (Full-Text)
None provided.More Information
Publications
- Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.
- Hambrecht R, Walther C, Möbius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. Epub 2004 Mar 8.
- Henderson RA, Pocock SJ, Clayton TC, Knight R, Fox KA, Julian DG, Chamberlain DA; Second Randomized Intervention Treatment of Angina (RITA-2) Trial Participants. Seven-year outcome in the RITA-2 trial: coronary angioplasty versus medical therapy. J Am Coll Cardiol. 2003 Oct 1;42(7):1161-70.
- Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996 Jul 6;313(7048):36-9. Erratum in: BMJ 1996 Aug 31;313(7056):550.
- Pitt B, Waters D, Brown WV, van Boven AJ, Schwartz L, Title LM, Eisenberg D, Shurzinske L, McCormick LS. Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease. Atorvastatin versus Revascularization Treatment Investigators. N Engl J Med. 1999 Jul 8;341(2):70-6.
- Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. Review.
- Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994 Dec 15;74(12):1240-4.
- Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995 Feb;25(2):333-41.
- Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58.
- Sullivan M, Karlsson J. The Swedish SF-36 Health Survey III. Evaluation of criterion-based validity: results from normative population. J Clin Epidemiol. 1998 Nov;51(11):1105-13.
- Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group, Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771.
- Dnr: 056-08