MACCE After Endoscopic Vein Harvest for CABG

NCT ID: NCT02471456

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complications Due to Coronary Artery Bypass Graft

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EVH

Patients that have undergone Endoscopic Vein Harvesting (EVH)

Quality of Life Questionnaire

Intervention Type OTHER

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

MACCE review

Intervention Type OTHER

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)

Quality of Life Questionnaire

Intervention Type OTHER

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

MACCE review

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality of Life Questionnaire

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

Intervention Type OTHER

MACCE review

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maquet Cardiovascular

INDUSTRY

Sponsor Role collaborator

The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heyman Luckraz

Role: PRINCIPAL_INVESTIGATOR

The Royal Wolverhampton NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Royal Wolverhampton NHS Trust

Wolverhampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015CAR76

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Drainage Technique in CABG
NCT07194798 NOT_YET_RECRUITING