This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 April 2017 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: April 4, 2017
Last verified: April 2017
  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: 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

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
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    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
Study First Received: April 15, 2013
Last Updated: April 4, 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

ClinicalTrials.gov processed this record on July 21, 2017