Ischemic Heart DiseaseNCT02547194
Graft Patency as a Predictor of Health-related Quality of Life.
An observational study of Ischemic Heart Disease and Atherosclerosis, run by Örebro County Council at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease, Atherosclerosis
- How many people
- 254 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to Mar 2016
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Substantial missing data from the EQ-5D questionnaire.
- Unable to comprehend the different inquiries in the questionnaire.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital
Örebro, 70185
About this study
Official title: 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.
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Keywords
- coronary artery bypass grafting, saphenous vein, no-touch technique
- Medical subject headings
- Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No touch vein grafts | The grafts were harvested with there surrounding tissues. | |
| Conventional vein grafts. | The grafts were stripped from surrounding tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-15 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ninos Samano M.D., Örebro University, Sweden
- Investigators
- Ninos Samano, MD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547194
- Sponsor's protocol ID
- 167861
- Status last verified
- Mar 2016
- First submitted
- 9 Sep 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28040753