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OpenTrials
Completed

NCT Number: NCT01510821

Investigation of Endothelium in Saphenous Vein Grafts

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.

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Key information

Conditions

Endothelial Function of Saphenous Vein Grafts

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiothoracic Surgery Research Laboratory, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Other

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Other names: Maquet device

Use of non-regulated syringe on SVG

Other

Use of non-regulated syringe on SVG

Other names: standard syringe

Primary outcomes

  1. SVG vascular contractility

    Time frame: Day of surgery

Secondary outcomes

  1. Nitric oxide metabolite levels

    Time frame: Day of surgery

  2. Major adverse cardiac events

    Time frame: 6 months and 1 year

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Maquet Cardiovascular

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 18, 2012
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.