Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting (IMPROVE-CABG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01834846
First received: April 15, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.


Condition Intervention
Myocardial Ischemia
Procedure: no-touch
Procedure: conventional

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Graft function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Graft function as evaluated by coronary angiography


Secondary Outcome Measures:
  • Morphological appearance of vein graft [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by angiography follow-up

  • Postoperative leg wound complications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    The following measures will be assessed at a 6 week follow up:

    • Signs of infection
    • Wound dehiscence
    • Aesthetics
    • Cutaneous sensory loss
    • Wound discomfort

  • Postoperative complications related to cardiac surgery [ Time Frame: Discharge, 6 weeks, 6 months ] [ Designated as safety issue: No ]
    • Major adverse cardiac and cerebral events
    • Postoperative complications
    • Reoperation
    • Sternal dehiscence
    • Mediastinitis


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: no-touch
no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting
Procedure: no-touch
The saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and left in situ until extracorporeal circulation is started to allow continuous heparinized blood perfusion. After removal, the vein is stored in blood obtained from the aortic cannula before cooling. To check for leakage from side branches and the distal anastomosis, the proximal end of the graft is briefly connected to the arterial cannula.
Active Comparator: conventional
conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting
Procedure: conventional
The saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended with saline using a syringe and stored in saline at room temperature, according to standard procedure at St. Olav's Hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Isolated elective, primary CABG requiring cardiopulmonary bypass
  • Left ventricular ejection fraction >35%
  • at least one saphenous vein graft required as part of revascularization strategy

Exclusion Criteria:

  • Acute or chronic inflammatory diseases
  • Malignancies
  • Pregnancy
  • Previous cardiac surgery
  • Serum creatinine >120 μmol/L
  • Coagulopathy
  • Insulin dependent diabetes mellitus
  • Smoking during last 6 months
  • Leg not suitable for No-touch vein harvesting as judged by the operator.
  • Need for nitrates on operation day
  • not receiving statins
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834846

Contacts
Contact: Øystein Pettersen, MSc oystein.pettersen@ntnu.no
Contact: Dag Ole Nordhaug, md phd dag.ole.nordhaug@stolav.no

Locations
Norway
Institute for Circulation and Imaging Recruiting
Trondheim, Sør-Trøndelag, Norway, 7042
Contact: Øystein Pettersen, Cand Med    004793628232    oystein.pettersen@ntnu.no   
Contact: Dag Ole Nordhaug, Dr Med       dag.ole.nordhaug@stolav.no   
Sub-Investigator: Øystein Pettersen, CAnd Med         
Principal Investigator: Dag Ole Nordhaug, Dr Med         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Dag Ole Nordhaug, md phd Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01834846     History of Changes
Other Study ID Numbers: 090486
Study First Received: April 15, 2013
Last Updated: July 25, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
comparative study
Cardiac Surgical Procedures

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014