Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris (LOBSTR)
Primary Purpose
Stable Angina Pectoris
Status
Withdrawn
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Percutaneous coronary angioplasty (PCI)
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina Pectoris focused on measuring stable coronary artery disease, quality of life, target achievement, physical training, percutaneous coronary intervention
Eligibility 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
Sites / Locations
- Sahlgrenska University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Without PCI
With PCI
Arm Description
Optimized medical treatment, physical training and smoking cessation
optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI)
Outcomes
Primary Outcome Measures
Quality of life measured by SF36
Secondary Outcome Measures
Achievement of target of treatment based on interview of the patients
Death, myocardial infarction, stroke or new revascularization
To assess expectations of treatment at inclusion and fulfilment of expectations
Quality of life measured by EQ5D and Seattle angina questionaire
Health economy
Full Information
NCT ID
NCT00825604
First Posted
January 20, 2009
Last Updated
May 20, 2019
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00825604
Brief Title
Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris
Acronym
LOBSTR
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Because of poor inclusion difficulties to find patient
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris
Keywords
stable coronary artery disease, quality of life, target achievement, physical training, percutaneous coronary intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without PCI
Arm Type
No Intervention
Arm Description
Optimized medical treatment, physical training and smoking cessation
Arm Title
With PCI
Arm Type
Active Comparator
Arm Description
optimized medical treatment, physical training and smoking cessation with complimentary treatment with percutaneous coronary intervention(PCI)
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary angioplasty (PCI)
Other Intervention Name(s)
PCI
Intervention Description
optimized medical treatment, physical training and smoking cessation with complimentary treatment with coronary angioplasty (PCI):
Primary Outcome Measure Information:
Title
Quality of life measured by SF36
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Achievement of target of treatment based on interview of the patients
Time Frame
6 months
Title
Death, myocardial infarction, stroke or new revascularization
Time Frame
6 months, one year and five years after randomization
Title
To assess expectations of treatment at inclusion and fulfilment of expectations
Time Frame
6 months
Title
Quality of life measured by EQ5D and Seattle angina questionaire
Time Frame
6 months and 5 years
Title
Health economy
Time Frame
6 months, one year and five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Grip, Prof.
Organizational Affiliation
Göteborgs Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
17387127
Citation
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Results Reference
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Citation
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Results Reference
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Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris
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