Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

April 2, 2019 updated by: Ron Fiehler, St. Luke's Hospital, Chesterfield, Missouri
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.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • St. Luke's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must be 25-95 years of age and able to give informed consent
  2. Use of an approved statin and anti-platelet medication for at least 24 months.
  3. Agreeable to Cardiovascular imaging at 12 months post-coronary artery bypass graft (CABG).
  4. 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:

  1. Acute traumatic injury, vasculitis or planned concurrent ventricular surgical restoration, automatic implantable cardioverter defibrillators (AICD) placement or valvular surgery.
  2. Hypercoaguable state.
  3. Comorbid illness making 2 year survival unlikely.
  4. 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.
  5. 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).
  6. 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.
  7. Any patient was has undergone more than 20 computerized tomography (CAT) scans.
  8. Any patient who is pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lactated Ringers Solution with Arginine
100 ml of LRS with arginine
Vein soak treated with polyarginine
Placebo Comparator: Lactated Ringers Solution
Lactated ringers solution
Vein soak

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronald D Leidenfrost, MD, St. Luke's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 11, 2011

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

3
Subscribe