Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MACCE After Endoscopic Vein Harvest for CABG (MAQEH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471456
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Maquet Cardiovascular
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

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.

Condition or disease Intervention/treatment
Complications Due to Coronary Artery Bypass Graft Other: Quality of Life Questionnaire Other: MACCE review

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : October 16, 2015
Actual Study Completion Date : October 16, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EVH
Patients that have undergone Endoscopic Vein Harvesting (EVH)
Other: Quality of Life Questionnaire
Quality of Life Questionnaire will be completed at least 1 year after their surgery.

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

OVH
Patients that have undergone open vein harvest (OVH)
Other: Quality of Life Questionnaire
Quality of Life Questionnaire will be completed at least 1 year after their surgery.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Fifty patients who underwent EVH (Study group) were part of our service evaluation when EVH was introduced to our practice. These patients were matched with patients undergoing CABG during the same period but where the LSV was harvested by OVH (50 patients, control group).

This service evaluation showed a significant cost benefit when EVH was used in terms of reduction in the inhopsital stay, leg wound pain, leg wound infection and need to attend wound clinic. The current study is an extension of the service evaluation to assess how these patients are doing at least a year after their surgery in terms of MACCE, QOL,return to normal activities and survival

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471456


Locations
Layout table for location information
United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Maquet Cardiovascular
Investigators
Layout table for investigator information
Principal Investigator: Heyman Luckraz The Royal Wolverhampton NHS Trust
Layout table for additonal information
Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02471456    
Other Study ID Numbers: 2015CAR76
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017