Endothelial Function in Human Arteries

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00848302

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction	Drug: L-arginine	Early Phase 1

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

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endothelial Function in Human Arteries

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: L-arginine Assess the effects of regional L-arginine supplementation in patients with chronic lower extremity occlusive disease undergoing angiography	Drug: L-arginine 30 patients will receive either 50, 100 or 500mg L-arginine supplementation infused via a end-hole catheter Other Names: Nitric oxide

Arm

Intervention/Treatment

Experimental: L-arginine

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

Drug: L-arginine

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

Other Names:

Nitric oxide

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Vikram Kashyap, MD, Cleveland Clinic Vascular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT00848302

Other Study ID Numbers:

K23HLOBO247
K23HLOBO247

First Posted:

Feb 20, 2009

Last Update Posted:

Mar 7, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by The Cleveland Clinic

peripheral vascular disease

endothelial dysfunction

intravascular ultrasound

L-Arginine

Additional relevant MeSH terms:

Nitric Oxide

Study Results

No Results Posted as of Mar 7, 2017