MACCE After Endoscopic Vein Harvest for CABG

Complications Due to Coronary Artery Bypass Graft Clinical Trial

— MAQEH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471456
• Other study ID #: 2015CAR76
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: June 20, 2017
• Start date: July 2015
• Est. completion date: October 16, 2015

Study information

• Verified date: June 2017
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 16, 2015
• Est. primary completion date: October 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications Due to Coronary Artery Bypass Graft

Intervention

Other:
• Quality of Life Questionnaire
Quality of Life Questionnaire will be completed at least 1 year after their surgery.
• MACCE review
MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.

Locations

Country	Name	City	State
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust	Maquet Cardiovascular

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QOL as assessed by the SF12v2 questionnaire	The review of QOL will occur at least 1 year after the patient's operation	approximately 1 year
Secondary	Time taken to return to regular daily activities	The review of time taken to return to regular daily activities will occur at least 1 year after the patient's operation	approximately 1 year
Secondary	Survival		at approximately 1 year