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Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes

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ClinicalTrials.gov Identifier: NCT01313533
Recruitment Status : Recruiting
First Posted : March 11, 2011
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Ron Fiehler, St. Luke's Hospital, Chesterfield, Missouri

March 10, 2011
March 11, 2011
October 14, 2016
March 2015
December 2019   (Final data collection date for primary outcome measure)
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
To study the effects of arginine on saphenous vein graft patency rates [ Time Frame: 12 months post op ]
To study the effects of arginine on saphenous vein graft patency rates
Complete list of historical versions of study NCT01313533 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
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.
Double blind study with Lactated Ringers Solution and Lactated Ringers Solution with Arginine soaked for 10 minutes prior to grafting on the coronary arteries.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atherosclerosis
  • Drug: Polyarginine
    Vein soak treated with polyarginine
  • Drug: Vein soak treated with Lactated Ringers Solution
    Vein soak
  • Active Comparator: Lactated Ringers Solution with Arginine
    100 ml of LRS with arginine
    Intervention: Drug: Polyarginine
  • Placebo Comparator: Lactated Ringers Solution
    Lactated ringers solution
    Intervention: Drug: Vein soak treated with Lactated Ringers Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
Same as current
November 2021
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
25 Years to 95 Years   (Adult, Older Adult)
No
Contact: Ronald D Leidenfrost, M.D. 314-304-3049 drron7103@yahoo.com
Contact: Ronald A Fiehler, RN 314-434-3049 medadvant@sbcglobal.net
United States
 
 
NCT01313533
R9-LRS-CS-01
Yes
Not Provided
Plan to Share IPD: Undecided
Ron Fiehler, St. Luke's Hospital, Chesterfield, Missouri
St. Luke's Hospital, Chesterfield, Missouri
Not Provided
Principal Investigator: Ronald D Leidenfrost, MD St. Luke's Hospital
St. Luke's Hospital, Chesterfield, Missouri
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP