AtherosclerosisPhase 1/2NCT01313533
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
A Phase 1/2 study testing Polyarginine and Vein soak treated with Lactated Ringers Solution in people with Atherosclerosis, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 95 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Polyarginine and Vein soak treated with Lactated Ringers Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Nov 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Luke's Hospital
Chesterfield, Missouri, 63017
Ronald D Leidenfrost, MD, 314-434-3049, drron7103@aol.com
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Polyarginine, Vein soak treated with Lactated Ringers Solution
- Keywords
- Atherosclerosis of Autologous Vein Bypass Graft
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyarginineDrug
Vein soak treated with polyarginine
Vein soak treated with Lactated Ringers SolutionDrug
Vein soak
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringers Solution with Arginine | Active comparator | 100 ml of LRS with arginine Receives: Drug: Polyarginine |
| Lactated Ringers Solution | Placebo comparator | Lactated ringers solution Receives: Drug: Vein soak treated with Lactated Ringers Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effects of arginine on saphenous vein graft patency rates
To study the effects of arginine on saphenous vein graft patency rates
Measured: 12 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2015
- Primary completionDec 2019 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Fiehler, St. Luke's Hospital, Chesterfield, Missouri
- Investigators
- Ronald D Leidenfrost, MD, Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313533
- Sponsor's protocol ID
- R9-LRS-CS-01
- Status last verified
- Apr 2019
- First submitted
- 10 Mar 2011
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
- ClinicalTrials.gov ID
- NCT01313533
- Acronym / sponsor ID
- R9-LRS-CS-01
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis of Autologous Vein Bypass Graft
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, Chesterfield, MissouriUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringers Solution with Arginine | Active comparator | Drug: Polyarginine100 ml of LRS with arginine |
| Lactated Ringers Solution | Placebo comparator | Drug: Vein soak treated with Lactated Ringers SolutionLactated ringers solution |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyarginineVein soak treated with polyarginine | Drug | Lactated Ringers Solution with Arginine |
| Vein soak treated with Lactated Ringers SolutionVein soak | Drug | Lactated Ringers Solution |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald D Leidenfrost, MD principal investigator
St. Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polyarginine and Vein soak treated with Lactated Ringers Solution in people with Atherosclerosis, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald D Leidenfrost, M.D. (314-304-3049, drron7103@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the effects of arginine on saphenous vein graft patency rates (time frame: 12 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.