NCT01313533

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
4 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

4.8 years

First QC Date

March 10, 2011

Last Update Submit

April 2, 2019

Conditions

Atherosclerosis

Keywords

Atherosclerosis of Autologous Vein Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lactated Ringers Solution with Arginine

ACTIVE COMPARATOR

100 ml of LRS with arginine

Drug: Polyarginine

Lactated Ringers Solution

PLACEBO COMPARATOR

Lactated ringers solution

Drug: Vein soak treated with Lactated Ringers Solution

Interventions

PolyarginineDRUG

Vein soak treated with polyarginine

Lactated Ringers Solution with Arginine
Vein soak treated with Lactated Ringers SolutionDRUG

Vein soak

Lactated Ringers Solution

Eligibility Criteria

Age25 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

polyarginineRinger's Lactate

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ronald D Leidenfrost, MD

    St. Luke's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald D Leidenfrost, M.D.

CONTACT

314-304-3049drron7103@yahoo.com

Ronald A Fiehler, RN

CONTACT

314-434-3049medadvant@sbcglobal.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 11, 2011

Study Start

March 1, 2015

Primary Completion

December 1, 2019

Study Completion

November 1, 2021

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

US(1)