MACCE After Endoscopic Vein Harvest for CABG
MAQEH
Major Adverse Cardiac and Cerebrovascular Event (MACCE) & Patients' Quality of Life (QOL) After Endoscopic Vein Harvesting as Compared to Open Vein Harvest for Coronary Artery Bypass Grafting
1 other identifier
observational
100
1 country
1
Brief Summary
Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous vein (LSV) harvesting from the leg. This has been reported to be associated with a significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50% of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a reduction in these complications was implemented within the investigators' service in 2012. Although some initial reports of concerns regarding graft patency when the LSV is harvested by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of the EVH technology. Last year a service evaluation in the investigators' department showed significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50 EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent to patients along with a patient information sheet. It is estimated that data collection would be completed within 3 months of start.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2015
CompletedJune 21, 2017
June 1, 2017
4 months
June 9, 2015
June 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH
The review of MACCE will occur at least 1 year after the patient's operation
approximately 1 year
Secondary Outcomes (3)
QOL as assessed by the SF12v2 questionnaire
approximately 1 year
Time taken to return to regular daily activities
approximately 1 year
Survival
at approximately 1 year
Study Arms (2)
EVH
Patients that have undergone Endoscopic Vein Harvesting (EVH)
OVH
Patients that have undergone open vein harvest (OVH)
Interventions
Quality of Life Questionnaire will be completed at least 1 year after their surgery.
MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.
Eligibility Criteria
Fifty patients who underwent EVH (Study group) were part of our service evaluation when EVH was introduced to our practice. These patients were matched with patients undergoing CABG during the same period but where the LSV was harvested by OVH (50 patients, control group). This service evaluation showed a significant cost benefit when EVH was used in terms of reduction in the inhopsital stay, leg wound pain, leg wound infection and need to attend wound clinic. The current study is an extension of the service evaluation to assess how these patients are doing at least a year after their surgery in terms of MACCE, QOL,return to normal activities and survival
You may qualify if:
- Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
- LSV harvested by EVH (Study group)
- LSV Harvested by OVH matched with EVH group (Control group)
You may not qualify if:
- \. Patient deceased at time of study start
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Royal Wolverhampton Hospitals NHS Trustlead
- Maquet Cardiovascularcollaborator
Study Sites (1)
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Heyman Luckraz
The Royal Wolverhampton NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 15, 2015
Study Start
July 1, 2015
Primary Completion
October 16, 2015
Study Completion
October 16, 2015
Last Updated
June 21, 2017
Record last verified: 2017-06