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Clinical Trials/NCT02471456
NCT02471456
Completed
Not Applicable

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

The Royal Wolverhampton Hospitals NHS Trust1 site in 1 country100 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complications Due to Coronary Artery Bypass Graft
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
Enrollment
100
Locations
1
Primary Endpoint
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
October 16, 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Patient deceased at time of study start

Outcomes

Primary Outcomes

MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH

Time Frame: approximately 1 year

The review of MACCE will occur at least 1 year after the patient's operation

Secondary Outcomes

  • Time taken to return to regular daily activities(approximately 1 year)
  • Survival(at approximately 1 year)
  • QOL as assessed by the SF12v2 questionnaire(approximately 1 year)

Study Sites (1)

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