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Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Polyarginine
Vein soak treated with Lactated Ringers Solution
Sponsored by
St. Luke's Hospital, Chesterfield, Missouri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Atherosclerosis of Autologous Vein Bypass Graft

Eligibility Criteria

25 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Luke's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lactated Ringers Solution with Arginine

Lactated Ringers Solution

Arm Description

100 ml of LRS with arginine

Lactated ringers solution

Outcomes

Primary Outcome Measures

To study the effects of arginine on saphenous vein graft patency rates
To study the effects of arginine on saphenous vein graft patency rates

Secondary Outcome Measures

Full Information

First Posted
March 10, 2011
Last Updated
April 2, 2019
Sponsor
St. Luke's Hospital, Chesterfield, Missouri
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1. Study Identification

Unique Protocol Identification Number
NCT01313533
Brief Title
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
Official Title
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital, Chesterfield, Missouri

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Atherosclerosis of Autologous Vein Bypass Graft

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactated Ringers Solution with Arginine
Arm Type
Active Comparator
Arm Description
100 ml of LRS with arginine
Arm Title
Lactated Ringers Solution
Arm Type
Placebo Comparator
Arm Description
Lactated ringers solution
Intervention Type
Drug
Intervention Name(s)
Polyarginine
Intervention Description
Vein soak treated with polyarginine
Intervention Type
Drug
Intervention Name(s)
Vein soak treated with Lactated Ringers Solution
Intervention Description
Vein soak
Primary Outcome Measure Information:
Title
To study the effects of arginine on saphenous vein graft patency rates
Description
To study the effects of arginine on saphenous vein graft patency rates
Time Frame
12 months post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald D Leidenfrost, M.D.
Phone
314-304-3049
Email
drron7103@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald A Fiehler, RN
Phone
314-434-3049
Email
medadvant@sbcglobal.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald D Leidenfrost, MD
Organizational Affiliation
St. Luke's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald D Leidenfrost, MD
Phone
314-434-3049
Email
drron7103@aol.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

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