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

This study is currently recruiting participants.
Verified April 2017 by Norwegian University of Science and Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT01834846
First Posted: April 18, 2013
Last Update Posted: April 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    Graft function as evaluated by coronary angiography in the first 60 out of 100 patients

  • Graft function [ Time Frame: 5 years ]
    Graft function as evaluated by coronary angiography in all 100 patients


Secondary Outcome Measures:
  • Morphological appearance of vein graft [ Time Frame: 6 months ]
    As measured by angiography follow-up in the first 60 out of 100 patients

  • Morphological appearance of vein graft [ Time Frame: 5 years ]
    As measured by angiography follow-up in all 100 patients

  • Postoperative leg wound complications [ Time Frame: 6 weeks ]

    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 ]

    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 ]

    Major adverse cardiac and cerebral events in all 100 patients

    • Postoperative complications
    • Reoperation
    • Sternal dehiscence
    • Mediastinitis


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (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 manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
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 and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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    004793628232    oystein.pettersen@ntnu.no   
Contact: Dag Ole Nordhaug, md phd       dag.ole.nordhaug@stolav.no   
Sub-Investigator: Øystein Pettersen         
Principal Investigator: Dag Ole Nordhaug, md phd         
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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01834846     History of Changes
Other Study ID Numbers: 090486
First Submitted: April 15, 2013
First Posted: April 18, 2013
Last Update Posted: April 6, 2017
Last Verified: April 2017

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

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


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