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Investigation of Endothelium in Saphenous Vein Grafts

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ClinicalTrials.gov Identifier: NCT01510821
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : October 1, 2013
Sponsor:
Collaborator:
Maquet Cardiovascular
Information provided by (Responsible Party):
Vinod Thourani, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
Endothelial Function of Saphenous Vein Grafts Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG Other: Use of non-regulated syringe on SVG Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. SVG vascular contractility [ Time Frame: Day of surgery ]

Secondary Outcome Measures :
  1. Nitric oxide metabolite levels [ Time Frame: Day of surgery ]
  2. Major adverse cardiac events [ Time Frame: 6 months and 1 year ]


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01510821


Locations
United States, Georgia
Cardiothoracic Surgery Research Laboratory
Atlanta, Georgia, United States, 30308
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Maquet Cardiovascular
Investigators
Principal Investigator: Vinod Thourani, MD Emory University

Responsible Party: Vinod Thourani, Associate Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT01510821     History of Changes
Other Study ID Numbers: IRB00049331
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

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