Recruiting
Phase 1
Phase 2

Polyarginine

Sponsor:

St. Luke's Hospital, Chesterfield, Missouri

Code:

NCT01313533

Conditions

Atherosclerosis

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Polyarginine

Vein soak treated with Lactated Ringers Solution

Study Details

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.

Conditions

Atherosclerosis

Study ID

NCT01313533

Start date

Mar, 2015

Status verified date

Apr, 2019

Completion date

Nov, 2021

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Lactated Ringers Solution with Arginine

100 ml of LRS with arginine

placebo comparator: Lactated Ringers Solution

Lactated ringers solution

Interventions

Polyarginine

Vein soak treated with polyarginine

Vein soak treated with Lactated Ringers Solution

Vein soak

Primary outcome measure

  • To study the effects of arginine on saphenous vein graft patency rates [ Time Frame: 12 months post operation ]

Central Contacts and Locations

Central contacts

Ronald D Leidenfrost, M.D.

314-304-3049drron7103@yahoo.com

Locations

St. Luke's Hospital

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Ronald D Leidenfrost, MD

314-434-3049drron7103@aol.com

More Information

Sponsor

St. Luke's Hospital, Chesterfield, Missouri

Last update posted

Apr 4, 2019

Last verified

Apr, 2019

Keywords

  • Atherosclerosis of Autologous Vein Bypass Graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Luke's Hospital, Chesterfield, Missouri on 2019-04-04.