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

NCT02547194 | Completed

• 1 other identifier: 167861
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Disease; Atherosclerosis

Keywords

coronary artery bypass grafting; saphenous vein; no-touch technique

Outcome Measures

Primary Outcomes (1)

• The health-related quality of life.

  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.

Study Arms (2)

No touch vein grafts

The grafts were harvested with there surrounding tissues.

Conventional vein grafts.

The grafts were stripped from surrounding tissue.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Örebro County Council: lead

Study Sites (1)

Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital

Örebro, 70185, Sweden

Location

Related Publications (1)

• Samano N, Bodin L, Karlsson J, Geijer H, Arbeus M, Souza D. Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):388-394. doi: 10.1093/icvts/ivw372.

  PMID: 28040753 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Atherosclerosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ninos Samano, MD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiothoracic Surgeon

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

SE (1)