Peripheral Arterial DiseaseNCT00759707
Endothelial Function in Lower Extremity Bypass Grafts
A study testing L-N^G monomethyl arginine (L-NMMA) in people with Peripheral Arterial Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- L-N^G monomethyl arginine (L-NMMA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts
Who cannot join
- Amputation beyond the toes
- Critical limb ischemia defined as rest pain, non-healing ulceration or gangrene
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow.
Read the detailed description
Subjects who have undergone saphenous vein [arterial] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) Subjects will then be given sub-lingual nitroglycerin, and repeat ultrasound will be performed 3 minutes later. Following 10 minutes of rest, subjects will be given intravenous L-NMMA, a specific nitric oxide inhibitor, to help determine the responsible agent of the vein graft flow mediated dilation.
- Conditions
- Peripheral Arterial Disease
- Being tested
- L-N^G monomethyl arginine (L-NMMA)
- Keywords
- saphenous vein bypass grafts, flow-mediated vasodilation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-N^G monomethyl arginine (L-NMMA)Drug
L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein [arterial] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-NMMA.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA. Receives: Drug: L-N^G monomethyl arginine (L-NMMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.
Measured: Single visit study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startApr 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua A. Beckman, MD, Brigham and Women's Hospital
- Investigators
- Joshua A. Beckman, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759707
- Sponsor's protocol ID
- 2006P-000424
- Status last verified
- Apr 2017
- First submitted
- 24 Sep 2008
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function in Lower Extremity Bypass Grafts
- ClinicalTrials.gov ID
- NCT00759707
- Acronym / sponsor ID
- 2006P-000424
- Conditions
- Peripheral Arterial Disease
- Keywords
- saphenous vein bypass grafts, flow-mediated vasodilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow.
Detailed description
Subjects who have undergone saphenous vein [arterial] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) Subjects will then be given sub-lingual nitroglycerin, and repeat ultrasound will be performed 3 minutes later. Following 10 minutes of rest, subjects will be given intravenous L-NMMA, a specific nitric oxide inhibitor, to help determine the responsible agent of the vein graft flow mediated dilation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: L-N^G monomethyl arginine (L-NMMA)ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts
Key exclusion criteria (3 listed)
- Amputation beyond the toes
- Critical limb ischemia defined as rest pain, non-healing ulceration or gangrene
- Pregnancy
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 |
|---|---|---|
| L-N^G monomethyl arginine (L-NMMA)L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein [arterial] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-NMMA. | Drug | 1 |
Primary outcome
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
Time frame: Single visit study
Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Joshua A. Beckman, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-N^G monomethyl arginine (L-NMMA) in people with Peripheral Arterial Disease, run by Brigham and Women's Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 May 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation (time frame: Single visit study). 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 16 May 2017.