Endothelial Function in Human Arteries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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

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Endothelial Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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L-arginine

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

Group Type EXPERIMENTAL

L-arginine

Intervention Type DRUG

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

Interventions

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L-arginine

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

Intervention Type DRUG

Other Intervention Names

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Nitric oxide

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No