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Investigation of Endothelium in Saphenous Vein Grafts

This study is currently recruiting participants.
Verified January 2012 by Emory University
Sponsor:
Collaborator:
Maquet Cardiovascular, Inc.
Information provided by (Responsible Party):
Vinod Thourani, Emory University
ClinicalTrials.gov Identifier:
NCT01510821
First received: November 2, 2011
Last updated: January 14, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.


Condition Intervention
Endothelial Function of Saphenous Vein Grafts
 Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG
Other: Use of non-regulated syringe on SVG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • SVG vascular contractility [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nitric oxide metabolite levels [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Major adverse cardiac events [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maquet Vasoshield Arm
Pressure limiting syringe
 Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG
Use of Maquet Vasoshield Pressure-limiting syringe on SVG
Other Name: Maquet device
Active Comparator: Non-regulated Arm
standard non-regulated syringe
 Other: Use of non-regulated syringe on SVG
Use of non-regulated syringe on SVG
Other Name: standard syringe

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts

Exclusion Criteria:

  • patients undergoing any concomitant surgical procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510821

Contacts
Contact: Kim Baio, MSN 404-686-2513 kbaio@emory.edu
Contact: Alexis Neill, MSN 404-686-2513 alexis.neill@emoryhealthcare.org

Locations
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Sub-Investigator: David Lefer, PhD            
Cardiothoracic Surgery Reserach Laboratory Recruiting
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Maquet Cardiovascular, Inc.
Investigators
Principal Investigator: Vinod Thourani, MD Emory University
  More Information

No publications provided

Responsible Party: Vinod Thourani, Associate Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT01510821     History of Changes
Other Study ID Numbers: IRB-49331
Study First Received: November 2, 2011
Last Updated: January 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
endoscopic vein harvest
saphenous vein graft
endothelial function

ClinicalTrials.gov processed this record on May 22, 2013