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

NCT00825604 | Withdrawn Phase 2

• 1 other identifier: Dnr: 056-08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina Pectoris

Keywords

stable coronary artery disease; quality of life; target achievement; physical training; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Quality of life measured by SF36

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Without PCI

NO INTERVENTION

Optimized medical treatment, physical training and smoking cessation

With PCI

ACTIVE COMPARATOR

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

Procedure: Percutaneous coronary angioplasty (PCI)

Interventions

Percutaneous coronary angioplasty (PCI) PROCEDURE

optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):

Also known as: PCI

With PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sahlgrenska University hospital

Gothenburg, 41345, Sweden

Location

Related Publications (11)

• 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. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

  PMID: 17387127 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)00951-3.

  PMID: 14522473 BACKGROUND

• 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. doi: 10.1056/NEJM199907083410202.

  PMID: 10395630 BACKGROUND

• 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.

  PMID: 18703470 BACKGROUND

• 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. doi: 10.1016/s0895-4356(98)00102-4.

  PMID: 9817128 BACKGROUND

• 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. doi: 10.1016/0002-9149(94)90555-x.

  PMID: 7977097 BACKGROUND

• 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. doi: 10.1016/0735-1097(94)00397-9.

  PMID: 7829785 BACKGROUND

• 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. doi: 10.1016/0277-9536(95)00125-q.

  PMID: 8560302 BACKGROUND

• 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. doi: 10.1136/bmj.313.7048.36.

  PMID: 8664772 BACKGROUND

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

  PMID: 11491192 BACKGROUND

• Hambrecht R, Walther C, Mobius-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. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.

  PMID: 15007010 BACKGROUND

MeSH Terms

Conditions

Angina, Stable

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Lars Grip, Prof.

  Göteborgs Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 21, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

SE (1)