Long-term Results Following Endoscopic Vein Harvesting in Coronary Artery Bypass Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Aalborg Universityhospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Jan Jesper Andreasen, MD, PhD, Aalborg Hospital
ClinicalTrials.gov Identifier:
NCT01480726
First received: November 24, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

Vena saphena magna is still frequently used as graft material in coronary artery bypass grating(CABG, and vein grafts can harvest with either the conventional open technique (Ovh = open vein harvesting), or with less invasive endoscopic techniques (EVH = Endoscopic vein harvesting). The endoscopic techniques have been shown to reduce the incidence of postoperative wound complications while patients are more satisfied with the cosmetic result of the operation on the leg.

Non-randomized studies have raised doubts about patency rates of the vein grafts following EVH compared to OVH, while other studies failed to detect any problems in relation to this. There are only very few data on long-term patency rates from randomized studies.

The purpose of this study is to investigate clinical outcome and patency rates of the vein grafts following either EVH and OVH in 132 patients who underwent CABG for 4-7 years ago as part of a randomized study investigation wound complications. A cost-effectiveness analysis will also be performed.

The hypothesis is: Patency rates following EVH are worse compared to OVH in CABG 4-7 years postoperatively.


Condition
Angina Pectoris

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Versus Open Vein Harvest in Coronary Artery Bypass Grafting. Clinical and CT-angiographic Long-term Result From a Randomized Study.

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Patency rates of vein grafts [ Time Frame: 5-7 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrence of angina pectoris [ Time Frame: 5-7 years postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endoscopic vein harvest
Open vein harvest

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   43 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 132 patients who underwent CABG 4-7 years ago. All patients participated in a randomized study focusing on wound complications from the leg following either open or endoscopic vein harvest.

Criteria

Inclusion Criteria:

  • Patients who participated in the previous randomized study
  • Informed consent from the patient

Exclusion Criteria:

  • Survival until date of reexamination
  • No informed consent
  • CT scan of the heart will not be performed in patients with if: atrial fibrillation,p-creatinin >120 micromol/l, allergy to contrast, pregnancy, lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480726

Contacts
Contact: Jan J. Andreasen, MD, PhD +45 99322964 jja@rn.dk

Locations
Denmark
Aalborg Hospital Not yet recruiting
Aalborg, Denmark, 9100
Contact: Jan J. Andreasen, MD, PhD         
Principal Investigator: Jan J. Andreasen, MD, PhD         
Sponsors and Collaborators
Aalborg Universityhospital
Aalborg University
Investigators
Principal Investigator: Jan J. Andreasen, MD. PhD Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Jan Jesper Andreasen, MD, PhD, Head of Department, MD, PhD, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT01480726     History of Changes
Other Study ID Numbers: N20110023
Study First Received: November 24, 2011
Last Updated: November 28, 2011
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014