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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 June 2016 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: June 20, 2016
Last verified: June 2016

April 15, 2013
June 20, 2016
May 2013
December 2019   (final data collection date for primary outcome measure)
  • Graft function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Graft function as evaluated by coronary angiography in the first 60 out of 100 patients
  • Graft function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Graft function as evaluated by coronary angiography in all 100 patients
Graft function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Graft function as evaluated by coronary angiography
Complete list of historical versions of study NCT01834846 on ClinicalTrials.gov Archive Site
  • Morphological appearance of vein graft [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by angiography follow-up in the first 60 out of 100 patients
  • Morphological appearance of vein graft [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    As measured by angiography follow-up in all 100 patients
  • Postoperative leg wound complications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    The following measures will be assessed in the first 60 out of 100 patients:

    • 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 in the first 60 out of 100 patients

    • Postoperative complications
    • Reoperation
    • Sternal dehiscence
    • Mediastinitis
  • Postoperative complications related to cardiac surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Major adverse cardiac and cerebral events in all 100 patients

    • Postoperative complications
    • Reoperation
    • Sternal dehiscence
    • Mediastinitis
  • 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
Not Provided
Not Provided
 
Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting
Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Ischemia
  • 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 manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
  • 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 and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
  • Experimental: no-touch
    no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting
    Intervention: Procedure: no-touch
  • Active Comparator: conventional
    conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting
    Intervention: Procedure: conventional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2019
December 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Øystein Pettersen, MSc oystein.pettersen@ntnu.no
Contact: Dag Ole Nordhaug, md phd dag.ole.nordhaug@stolav.no
Norway
 
NCT01834846
090486
Yes
Not Provided
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Dag Ole Nordhaug, md phd Norwegian University of Science and Technology
Norwegian University of Science and Technology
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP