NCT00848302

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

February 12, 2009

Last Update Submit

March 6, 2017

Conditions

Endothelial Dysfunction

Keywords

peripheral vascular diseaseendothelial dysfunctionintravascular ultrasoundL-Arginine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Procedural

Study Arms (1)

L-arginine

EXPERIMENTAL

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

Drug: L-arginine

Interventions

L-arginineDRUG

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

Also known as: Nitric oxide
L-arginine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28366306DERIVED

  • Kashyap 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.

    PMID: 23830159DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

ArginineNitric Oxide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialReactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Study Officials

  • Vikram Kashyap, MD

    Cleveland Clinic Vascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 20, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share