Clinical Trials Directory

Trials / Completed

CompletedNCT02471456

MACCE After Endoscopic Vein Harvest for CABG

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
The Royal Wolverhampton Hospitals NHS Trust · Other Government
Sex
All
Age
40 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERQuality of Life QuestionnaireQuality of Life Questionnaire will be completed at least 1 year after their surgery.
OTHERMACCE reviewMACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.

Timeline

Start date
2015-07-01
Primary completion
2015-10-16
Completion
2015-10-16
First posted
2015-06-15
Last updated
2017-06-21

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02471456. Inclusion in this directory is not an endorsement.