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

May 20, 2019 updated by: Göteborg University

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life measured by SF36
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Lars Grip, Prof., Göteborgs Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr: 056-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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