Plain English Summary
Background and study aims
A coronary artery bypass graft (CABG) is a surgical procedure used to treat coronary heart disease. In coronary heart disease, the major arteries supplying blood to the heart become narrowed, or blocked, due to the build-up of fatty deposits (plaques). This condition is called atherosclerosis. A CABG is used to improve both blood and oxygen supply to the heart and reduce the risk of a heart attack. It involves taking a blood vessel from elsewhere in the body usually from the chest, arm or leg and attaching it above and below the portion of coronary artery that has been affected by atherosclerosis. The aim of this study is to compare three different ways to take out a leg vein (referred to as harvesting the vein) for CABG to see which one is the best technique.
Who can participate?
Adults who are at least 18 and undergoing CABG at the University Hospital of South Manchester (UK)
What does the study involve?
Patients are randomly allocated to undergo one of the three vein removal techniques and the removed vein is then used for CABG. A small sample of the vein in each case is taken to laboratory for further cell studies to look at how the cells that make up the vein have reacted to the different vein removal techniques used. The patients are also contacted by telephone every 3 months for the first year after surgery and then again 3 years and 5 years after the operation. On each of these occasions, a member of the research team asks them to complete a questionnaire about their progress.
What are the possible benefits and risks of participating?
This study will provide data which will guide selection of the best vein harvesting technique in future clinical practice. Possible postoperative risks include wound infection, wound gapping, pain and serous discharge (weeping) from the wound site.
Where is the study run from?
Cardiothoracic department and Transplant research laboratory, University Hospital of South Manchester NHS Foundation Trust, Manchester (UK)
When is the study starting and how long is it expected to run for?
January 2011 to January 2015
Who is funding the study?
1. NIHR CAT Clinical Research Fellowship (UK)
2. University Hospital of South Manchester (UK)
Who is the main contact?
Prof. Nizar Yonan
nizar.yonan@uhsm.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised study comparing Vein Integrity and Clinical Outcomes (VICO) in open vein harvesting and two types of endoscopic vein harvesting for Coronary Artery Bypass Surgery - The VICO trial.
Acronym
VICO
Study hypothesis
1. Is there any difference in [DOE1] vein integrity following vein harvesting with open vein harvesting (OVH), closed-tunnel endoscopic vein harvesting (CT-EVH) and open-tunnel endoscopic vein harvesting (OTEVH)?
2. Are there any differences in clinical outcomes (ie mortality, graft failure, myocardial infection) between OVH, CT-EVH and OT-EVH?
3. Is there any association between [DOE2] vein integrity and clinical outcomes?
4. Are there any differences in patient reported outcomes (ie health-related quality of life and satisfaction) between OVH, CT-EVH and OT-EVH?
5. Are there any differences in cost between these techniques?
Ethics approval
National Research Ethics Committee (NREC), ref: 12/NW/0572
Study design
Single-center randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Coronary artery bypass surgery
Intervention
Computer block randomisation assigned the patients to undergo an open vein harvesting (control group: n=150), Closed tunnel CO2 endoscopic vein harvesting (n=150) and Open tunnel CO2 endoscopic vein harvesting (n=150). The assignment number will be concealed in a closed envelope separately for each patient by an independent Statistical team member who are not involved in this study or involved to the research group. The envelope will be delivered and opened by the surgical team (as late as possible ), once the patient is anaesthetised for the surgery on the operating room.
Control group: Will receive a standard open vein harvesting with a long incision on their donor leg.
Group 1 : Closed tunnel : Will receive a endoscopic vein harvesting (Maquet EVH device) of two or three 2-3 cm cut in their donor leg.
Group 2: Open tunnel : Will receive a endoscopic vein harvesting (Sorin EVH device) of two or three 2-3 cm cut in their donor leg.
All the patients in this study will be donoating 3 cm (1cm x3) of vein samples will be collected from each patient during the surgery and will be send to the laboratory for tissue investigations.
All the patients will be followed up until their discharge from day 1 of their operation. They will be contact on the telephone at 3 month intervals within the first year, and then at 1,3 and 5 years.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Long saphenous vein integrity, as indicated by the level of histological damage
Secondary outcome measures
1. Post-surgical clinical outcomes, specifically major adverse cardiac events such as reoccurrence of angina, myocardial infarction, vein graft failure, mortality and wound complications
2. Patient reported outcomes: generic health related quality of life
3. Health economic analysis: the costs and effects of the three approaches to vein harvesting
Overall trial start date
01/01/2011
Overall trial end date
01/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients undergoing CABG surgery at the University Hospital of South Manchester
2. Aged 18 or over
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 patients for initial recruitment and the results will be analysed and discussed in the ethics meeting. If there is a need, the study will be continued until 450 patients recruitment
Participant exclusion criteria
1. Any patient who refuses or withdraws the consent
2. Patients undergoing emergency surgery or a contra-indication to a technique including varicose vein on the long saphenous vein, small or thin legs and a superficial LSV
Recruitment start date
01/01/2011
Recruitment end date
01/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wythenshawe Hospital
South Manchester
M239LT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
NIHR CAT Clinical Research Fellowship (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Hospital of South Manchester (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary