Investigation of Endothelium in Saphenous Vein Grafts

NCT01510821 | Completed DMC

• 1 other identifier: IRB00049331
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Endothelial Function of Saphenous Vein Grafts

Keywords

endoscopic vein harvest; saphenous vein graft; endothelial function

Outcome Measures

Primary Outcomes (1)

• SVG vascular contractility

  Day of surgery

Secondary Outcomes (2)

• Nitric oxide metabolite levels

  Day of surgery

• Major adverse cardiac events

  6 months and 1 year

Study Arms (2)

Maquet Vasoshield Arm

EXPERIMENTAL

Pressure limiting syringe

Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Non-regulated Arm

ACTIVE COMPARATOR

standard non-regulated syringe

Other: Use of non-regulated syringe on SVG

Interventions

Use of Maquet Vasoshield Pressure-limiting syringe on SVG OTHER

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Also known as: Maquet device

Maquet Vasoshield Arm

Use of non-regulated syringe on SVG OTHER

Use of non-regulated syringe on SVG

Also known as: standard syringe

Non-regulated Arm

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients undergoing any concomitant surgical procedures

Sponsors & Collaborators

• Emory University: lead
• Maquet Cardiovascular: collaborator

Study Sites (2)

Cardiothoracic Surgery Research Laboratory

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Study Officials

• Vinod Thourani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: January 18, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

US (2)