The Health-related Quality of Life of Patients Who Underwent Coronary Artery Bypass Surgery With the No-touch Technique.

Atherosclerosis Clinical Trial

Official title:

The Health-related Quality of Life of Patients Who Underwent Coronary Artery Bypass Surgery With the No-touch Vein Harvesting Technique.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02547194
• Other study ID #: 167861
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 10, 2015

Study information

• Verified date: September 2015
• Source: Örebro County Council
• Contact: Ninos Samano, MD
• Phone: +46196025917
• Email: ninos.samano[@]regionorebrolan.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Sweden	Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No