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

This study has been withdrawn prior to enrollment.
(Because of poor inclusion difficulties to find patient)
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00825604
First received: January 20, 2009
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Stable Angina Pectoris
Procedure: Percutaneous coronary angioplasty (PCI)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Stable Angina Pectoris.

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Quality of life measured by SF36 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of target of treatment based on interview of the patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Death, myocardial infarction, stroke or new revascularization [ Time Frame: 6 months, one year and five years after randomization ] [ Designated as safety issue: Yes ]
  • To assess expectations of treatment at inclusion and fulfilment of expectations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life measured by EQ5D and Seattle angina questionaire [ Time Frame: 6 months and 5 years ] [ Designated as safety issue: No ]
  • Health economy [ Time Frame: 6 months, one year and five years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PCI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825604

Locations
Sweden
Sahlgrenska University hospital
Göteborg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Lars Grip, Prof. Göteborgs Universty
  More Information

Publications:

Responsible Party: Lars Grip M D PhD Prof, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00825604     History of Changes
Other Study ID Numbers: Dnr: 056-08
Study First Received: January 20, 2009
Last Updated: March 16, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
stable coronary artery disease
quality of life
target achievement
physical training
percutaneous coronary intervention

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014