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MACCE After Endoscopic Vein Harvest for CABG (MAQEH)

T

The Royal Wolverhampton Hospitals NHS Trust

Status

Completed

Conditions

Complications Due to Coronary Artery Bypass Graft

Treatments

Other: Quality of Life Questionnaire
Other: MACCE review

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02471456
2015CAR76

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
  2. LSV harvested by EVH (Study group)
  3. LSV Harvested by OVH matched with EVH group (Control group)

Exclusion criteria

  1. Patient deceased at time of study start

Trial design

100 participants in 2 patient groups

EVH
Description:
Patients that have undergone Endoscopic Vein Harvesting (EVH)
Treatment:
Other: MACCE review
Other: Quality of Life Questionnaire
OVH
Description:
Patients that have undergone open vein harvest (OVH)
Treatment:
Other: MACCE review
Other: Quality of Life Questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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