Endothelial DysfunctionEarly Phase 1NCT00848302
Endothelial Function in Human Arteries
A Early Phase 1 study testing L-arginine in people with Endothelial Dysfunction, run by The Cleveland Clinic.
Trial summary
Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with L-arginine to assess changes in endothelial function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- L-arginine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 2011
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- symptoms of intermittent claudication, rest pain or minor tissue loss (Rutherford Category I-V)
- ABI of <.90
- angiographic demonstration of a 100mm patent segment of superficial femoral artery containing at least one distal runoff vessel
Who cannot join
- acute limb ischemia,
- contraindication to angiography (creatinine >2.5)
- concurrent oral anticoagulant therapy that cannot be safely withheld
- extensive tissue loss or gangrene
About this study
Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with L-arginine to assess changes in endothelial function.
Read the detailed description
We will assess doses of regional L-arginine supplementation in patients undergoing elective angiography for lower extremity PAD. Assessment of EDR and EIR with IVUS in patent arteries will be performed with one of 3 doses of catheter-directed L-arginine. We will obtain plasma samples from the peripheral arteries and assay amino acid levels and protein oxidation products using mass spectrometry. These experiments will determine the optimal L-arginine supplementation dose to be used in further studies. We expect to show that L-arginine supplementation will have a more significant effect on vessels less affected by atherosclerosis, but that this effect diminishes with greater atheroma accumulation as measured by IVUS virtual histology. Also, we expect L-arginine supplementation to be most effective in vessels with low baseline L-arginine levels. Lastly, we will compare local arterial factors obtained via catheter-directed arterial sampling (NOx, L-arginine, nitrotyrosine levels) to traditional serum risk factors (glucose, HbA1c, LDL, homocysteine and hs C-reactive protein).
- Conditions
- Endothelial Dysfunction
- Being tested
- L-arginine
- Keywords
- peripheral vascular disease, endothelial dysfunction, intravascular ultrasound, L-Arginine
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDrug
Also called Nitric oxide
30 patients will receive either 50, 100 or 500mg L-arginine supplementation infused via a end-hole catheter
| Study group | Role | What they receive |
|---|---|---|
| L-arginine | Experimental | Assess the effects of regional L-arginine supplementation in patients with chronic lower extremity occlusive disease undergoing angiography Receives: Drug: L-arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVUS mediated assessment of endothelial-dependent (EDR) and endothelial-independent (EIR) vasorelaxation before and after catheter-directed L-arginine delivery in patent arteries.
Measured: Procedural
Secondary outcomes (1)
Local arterial factors including peripheral L-arginine and nitrotyrosine levels via mass spectrometry and morphologic parameters of plaque composition.
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikram Kashyap, MD, Principal investigator, Cleveland Clinic Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848302
- Sponsor's protocol ID
- K23HLOBO247
- Other IDs
- K23HLOBO247
- Status last verified
- Mar 2017
- First submitted
- 12 Feb 2009
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kashyap VS, Lakin RO, Campos P, Allemang M, Kim A, Sarac TP, Hausladen A, Stamler JS. The LargPAD Trial: Phase IIA evaluation of l-arginine infusion in patients with peripheral arterial disease. J Vasc Surg. 2017 Jul;66(1):187-194. doi: 10.1016/j.jvs.2016.12.127. Epub 2017 Mar 30.
PubMed 28366306Kashyap VS, Lakin RO, Feiten LE, Bishop PD, Sarac TP. In vivo assessment of endothelial function in human lower extremity arteries. J Vasc Surg. 2013 Nov;58(5):1259-66. doi: 10.1016/j.jvs.2013.05.029. Epub 2013 Jul 3.
PubMed 23830159
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function in Human Arteries
- ClinicalTrials.gov ID
- NCT00848302
- Acronym / sponsor ID
- K23HLOBO247
- Conditions
- Endothelial Dysfunction
- Keywords
- peripheral vascular disease, endothelial dysfunction, intravascular ultrasound, L-Arginine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Feb 2009 (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.
Up to 30 patients with lower extremity disease scheduled to undergo diagnostic angiography will undergo baseline bloodwork and IVUS (intravascular ultrasound), followed by dosing with L-arginine to assess changes in endothelial function.
Detailed description
We will assess doses of regional L-arginine supplementation in patients undergoing elective angiography for lower extremity PAD. Assessment of EDR and EIR with IVUS in patent arteries will be performed with one of 3 doses of catheter-directed L-arginine. We will obtain plasma samples from the peripheral arteries and assay amino acid levels and protein oxidation products using mass spectrometry. These experiments will determine the optimal L-arginine supplementation dose to be used in further studies. We expect to show that L-arginine supplementation will have a more significant effect on vessels less affected by atherosclerosis, but that this effect diminishes with greater atheroma accumulation as measured by IVUS virtual histology. Also, we expect L-arginine supplementation to be most effective in vessels with low baseline L-arginine levels. Lastly, we will compare local arterial factors obtained via catheter-directed arterial sampling (NOx, L-arginine, nitrotyrosine levels) to traditional serum risk factors (glucose, HbA1c, LDL, homocysteine and hs C-reactive protein).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-arginine | Experimental | Drug: L-arginineAssess the effects of regional L-arginine supplementation in patients with chronic lower extremity occlusive disease undergoing angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >18 years
- symptoms of intermittent claudication, rest pain or minor tissue loss (Rutherford Category I-V)
- ABI of <.90
- angiographic demonstration of a 100mm patent segment of superficial femoral artery containing at least one distal runoff vessel
Key exclusion criteria (4 listed)
- acute limb ischemia,
- contraindication to angiography (creatinine >2.5)
- concurrent oral anticoagulant therapy that cannot be safely withheld
- extensive tissue loss or gangrene
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-arginineAlso: Nitric oxide30 patients will receive either 50, 100 or 500mg L-arginine supplementation infused via a end-hole catheter | Drug | L-arginine |
Primary outcome
IVUS mediated assessment of endothelial-dependent (EDR) and endothelial-independent (EIR) vasorelaxation before and after catheter-directed L-arginine delivery in patent arteries.
Time frame: Procedural
1 secondary outcome
Local arterial factors including peripheral L-arginine and nitrotyrosine levels via mass spectrometry and morphologic parameters of plaque composition.
Time frame: Procedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 28366306Kashyap VS, Lakin RO, Campos P, Allemang M, Kim A, Sarac TP, Hausladen A, Stamler JS. The LargPAD Trial: Phase IIA evaluation of l-arginine infusion in patients with peripheral arterial disease. J Vasc Surg. 2017 Jul;66(1):187-194. doi: 10.1016/j.jvs.2016.12.127. Epub 2017 Mar 30.
- Derived from this study: PubMed 23830159Kashyap VS, Lakin RO, Feiten LE, Bishop PD, Sarac TP. In vivo assessment of endothelial function in human lower extremity arteries. J Vasc Surg. 2013 Nov;58(5):1259-66. doi: 10.1016/j.jvs.2013.05.029. Epub 2013 Jul 3.
- 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.
Vikram Kashyap, MD principal investigator
Cleveland Clinic Vascular Surgery
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing L-arginine in people with Endothelial Dysfunction, run by The Cleveland Clinic.
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 4 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IVUS mediated assessment of endothelial-dependent (EDR) and endothelial-independent (EIR) vasorelaxation before and after catheter-directed L-arginine delivery in patent arteries. (time frame: Procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848302, which also lists 2 linked publications.
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 7 Mar 2017.