Graft Patency as a Predictor of Health-related Quality of Life.

March 29, 2016 updated by: Ninos Samano M.D., Örebro County Council

Graft Patency as a Predictor of Health-related Quality of Life in Coronary Artery Bypass Patients.

The health-related quality of life questionnaire "EQ-5D" has been collected in connection with several interventional and observational studies where the no-touch vein harvesting technique in CABG has been used. The results of the questionnaires will be compiled and reported in this study.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

254

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
      • Örebro, Sweden, 70185
        • Department for Cardiothoracic and Vascular Surgery, Örebro 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients included in the study have been operated on at the department of Cardiothoracic and Vascular Surgery, Orebro University Hospital, Orebro, Sweden.

Description

Inclusion Criteria:

  1. Operated at our department for a coronary artery bypass surgery with either the no-touch harvesting technique of conventional harvesting technique.
  2. Completed the EQ-5D questionnaire.
  3. Signed and dated consent.

Exclusion Criteria:

  1. Substantial missing data from the EQ-5D questionnaire.
  2. Unable to comprehend the different inquiries in the questionnaire.

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

Cohorts and Interventions

Group / Cohort
No touch vein grafts
The grafts were harvested with there surrounding tissues.
Conventional vein grafts.
The grafts were stripped from surrounding tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The health-related quality of life.
Time Frame: 5-15 years postoperatively.
EQ-5D is a generic measure of health. The instrument can be used to measure quality of life change in a population over time and to compare the quality of life among different groups in the population such as different socio-economic groups. EQ-5D is constructed of five dimensions: mobility, care, usual activities, pain / discomfort and anxiety / depression. Each dimension is answered on a three-point scale (none, moderate or severe symptoms). With this instrument, it can theoretically be 243 possible health conditions. Health condition can also be described as an index value between 0 corresponding to death and one equivalent full health. Some negative values corresponding a state worse than death can occur. Moreover consists EQ-5D of a VAS scale (Visual Analogue Scale), a thermometer-like scale, with 0 being the worst possible health status and 100 representing full health.
5-15 years postoperatively.

Collaborators and Investigators

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

Sponsor

Örebro County Council

Investigators

  • Principal Investigator: Ninos Samano, MD, Örebro University, Sweden

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

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 167861

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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