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Endothelial Function in Human Arteries

Endothelial Function in Human Arteries

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00848302
Enrollment
25
Registered
2009-02-20
Start date
2009-09-30
Completion date
2011-01-31
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction

Keywords

peripheral vascular disease, endothelial dysfunction, intravascular ultrasound, L-Arginine

Brief 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.

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).

Interventions

DRUGL-arginine

30 patients will receive either 50, 100 or 500mg L-arginine supplementation infused via a end-hole catheter

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* acute limb ischemia, * contraindication to angiography (creatinine \>2.5) * concurrent oral anticoagulant therapy that cannot be safely withheld * extensive tissue loss or gangrene

Design outcomes

Primary

MeasureTime frame
IVUS mediated assessment of endothelial-dependent (EDR) and endothelial-independent (EIR) vasorelaxation before and after catheter-directed L-arginine delivery in patent arteries.Procedural

Secondary

MeasureTime frame
Local arterial factors including peripheral L-arginine and nitrotyrosine levels via mass spectrometry and morphologic parameters of plaque composition.Procedural

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026