Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to study the effects of polyarginine treated vein grafts on graft patency for patients undergoing coronary artery bypass surgery.

Detailed Description
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Double blind study with Lactated Ringers Solution and Lactated Ringers Solution with Arginine soaked for 10 minutes prior to grafting on the coronary arteries.

Official Title
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Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Conditions
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Atherosclerosis

Intervention / Treatment
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* Drug: Polyarginine
* Drug: Vein soak treated with Lactated Ringers Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 25-95 years of age and able to give informed consent Use of an approved statin and anti-platelet medication for at least 24 months. Agreeable to Cardiovascular imaging at 12 months post-coronary artery bypass graft (CABG). First time coronary artery bypass surgery,redo coronary artery bypass surgery and combined valve repair/replacement surgery and coronary artery bypass graft surgery are eligible to participate in study. Exclusion Criteria: Acute traumatic injury, vasculitis or planned concurrent ventricular surgical restoration, automatic implantable cardioverter defibrillators (AICD) placement or valvular surgery. Hypercoaguable state. Comorbid illness making 2 year survival unlikely. Participation in another interventional investigative study of a cardiovascular drug or device within 30 days prior to CABG. May participate concurrently in other studies where the intervention/observation will not hinder execution of this study. Patients with any medical condition that, in the investigator's judgment, makes the patient ineligible or places the patient at undue risk (e.g. conditions that preclude standard invasive follow up procedures such as angiography, i.e. renal failure, bleeding diathesis or peripheral vascular disease preventing catheterization via the groin). Subject has clinical evidence of infection that the Investigator deems significant to the completion of the procedure or that could compromise the subject's safety. Any patient was has undergone more than 20 computerized tomography (CAT) scans. Any patient who is pregnant.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactated Ringers Solution with Arginine<br>100 ml of LRS with arginine | Drug: Polyarginine<br>* Vein soak treated with polyarginine<br>|
| Placebo Comparator: Lactated Ringers Solution<br>Lactated ringers solution | Drug: Vein soak treated with Lactated Ringers Solution<br>* Vein soak<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effects of arginine on saphenous vein graft patency rates | To study the effects of arginine on saphenous vein graft patency rates | 12 months post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis of Autologous Vein Bypass Graft