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Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by St. Luke's Hospital, Chesterfield, Missouri
Sponsor:
Information provided by (Responsible Party):
Ron Fiehler, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier:
NCT01313533
First received: March 10, 2011
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Atherosclerosis
Drug: Polyarginine
Drug: Vein soak treated with Lactated Ringers Solution
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

Resource links provided by NLM:


Further study details as provided by St. Luke's Hospital, Chesterfield, Missouri:

Primary Outcome Measures:
  • To study the effects of arginine on saphenous vein graft patency rates [ Time Frame: 12 months post operation ] [ Designated as safety issue: Yes ]
    To study the effects of arginine on saphenous vein graft patency rates


Estimated Enrollment: 540
Study Start Date: March 2015
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactated Ringers Solution with Arginine
100 ml of LRS with arginine
Drug: Polyarginine
Vein soak treated with polyarginine
Placebo Comparator: Lactated Ringers Solution
Lactated ringers solution
Drug: Vein soak treated with Lactated Ringers Solution
Vein soak

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.
  Eligibility

Ages Eligible for Study:   25 Years to 95 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313533

Contacts
Contact: Ronald D Leidenfrost, M.D. 314-304-3049 drron7103@yahoo.com
Contact: Ronald A Fiehler, RN 314-434-3049 medadvant@sbcglobal.net

Locations
United States, Missouri
St. Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Ronald D Leidenfrost, MD    314-434-3049    drron7103@aol.com   
Sponsors and Collaborators
St. Luke's Hospital, Chesterfield, Missouri
Investigators
Principal Investigator: Ronald D Leidenfrost, MD St. Luke's Hospital
  More Information

Responsible Party: Ron Fiehler, Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes, St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier: NCT01313533     History of Changes
Other Study ID Numbers: R9-LRS-CS-01 
Study First Received: March 10, 2011
Last Updated: October 12, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by St. Luke's Hospital, Chesterfield, Missouri:
Atherosclerosis of Autologous Vein Bypass Graft

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on January 17, 2017