PolyArginine Treated vEiN grafTs II (PATENT II)
This study is not yet open for participant recruitment.
Verified March 2011 by St. Luke's Hospital, Chesterfield, Missouri
Sponsor:
St. Luke's Hospital, Chesterfield, Missouri
Information provided by:
St. Luke's Hospital, Chesterfield, Missouri
ClinicalTrials.gov Identifier:
NCT01313533
First received: March 10, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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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: 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: | PolyArginine Treated vEiN grafTs II (PATENT II) |
Resource links provided by NLM:
MedlinePlus related topics:
Atherosclerosis
Drug Information available for:
Ringer's lactate
U.S. FDA Resources
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 op ] [ Designated as safety issue: Yes ]To study the effects of arginine on saphenous vein graft patency rates
| Estimated Enrollment: | 540 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lactated Ringers Solution with Arginine |
Drug: Polyarginine
Vein soak treated with polyarginine
|
| Placebo Comparator: Lactated Ringers Solution |
Drug: 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects must be 25-95 years of age and able to give informed consent.
- First, isolated coronary artery bypass graft surgery.
- Use of an apoproved statin and anti-platelet medication for at least 24 months.
- Agreeable to Cardiovascular imaging at 12 months post-CABG.
Exclusion Criteria:
- Acute traumatic injury, vasculitis or planned concurrrent ventricular surgical restoration, 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 standeard 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 CAT scans.
- Any patient who is pregnant.
Contacts and Locations
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 | Not yet 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
No publications provided
| Responsible Party: | Ronald Leidenfrost, M.D., Chief of Cardiothoracic Surgery St. Luke, St. Luke's Hospital |
| ClinicalTrials.gov Identifier: | NCT01313533 History of Changes |
| Other Study ID Numbers: | R9-LRS-CS-01 |
| Study First Received: | March 10, 2011 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Luke's Hospital, Chesterfield, Missouri:
|
Atherosclerosis of Autologous Vein Bypass Graft(s) of the Left Leg with Ulceration of Unspecified Site |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013