- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01313533
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
April 2, 2019 updated by: Ron Fiehler, St. Luke's Hospital, Chesterfield, Missouri
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
540
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ronald D Leidenfrost, M.D.
- Phone Number: 314-304-3049
- Email: drron7103@yahoo.com
Study Contact Backup
- Name: Ronald A Fiehler, RN
- Phone Number: 314-434-3049
- Email: medadvant@sbcglobal.net
Study Locations
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Recruiting
- St. Luke's Hospital
-
Contact:
- Ronald D Leidenfrost, MD
- Phone Number: 314-434-3049
- Email: drron7103@aol.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lactated Ringers Solution with Arginine
100 ml of LRS with arginine
|
Vein soak treated with polyarginine
|
Placebo Comparator: Lactated Ringers Solution
Lactated ringers solution
|
Vein soak
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months post operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ronald D Leidenfrost, MD, St. Luke's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
March 10, 2011
First Submitted That Met QC Criteria
March 10, 2011
First Posted (Estimate)
March 11, 2011
Study Record Updates
Last Update Posted (Actual)
April 4, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R9-LRS-CS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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