Endothelial Function in Human Arteries

NeuroTherapia, Inc.

Status and phase: Completed; Early Phase 1

Conditions: Endothelial Dysfunction

Treatments: Drug: L-arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT00848302

K23HLOBO247 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

L-arginine

Experimental group

Description:

Assess the effects of regional L-arginine supplementation in patients with chronic lower extremity occlusive disease undergoing angiography

Treatment:

Drug: L-arginine