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OpenTrials
Completed

NCT Number: NCT02471456

MACCE After Endoscopic Vein Harvest for CABG

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of Life Questionnaire

Other

Quality of Life Questionnaire will be completed at least 1 year after their surgery.

MACCE review

Other

MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.

Primary outcomes

  1. 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

  1. QOL as assessed by the SF12v2 questionnaire

    Time frame: approximately 1 year

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

  2. Time taken to return to regular daily activities

    Time frame: approximately 1 year

    The review of time taken to return to regular daily activities will occur at least 1 year after the patient's operation

  3. Survival

    Time frame: at approximately 1 year

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Collaborators

  • Maquet Cardiovascular

Registry information

Official study 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

Acronym: MAQEH

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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