Endothelial Function in Human Arteries

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00848302
First received: February 12, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Endothelial Dysfunction
Drug: L-arginine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endothelial Function in Human Arteries

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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. [ Time Frame: Procedural ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local arterial factors including peripheral L-arginine and nitrotyrosine levels via mass spectrometry and morphologic parameters of plaque composition. [ Time Frame: Procedural ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nitric oxide

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848302

Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Vikram Kashyap, MD Cleveland Clinic Vascular Surgery
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Vikram Kashyap, Cleveland Clinic--Vascular Surgery
ClinicalTrials.gov Identifier: NCT00848302     History of Changes
Other Study ID Numbers: K23HLOBO247, K23HLOBO247
Study First Received: February 12, 2009
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
peripheral vascular disease
endothelial dysfunction
intravascular ultrasound
L-Arginine

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014