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Endothelial Function in Human Arteries

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00848302
First received: February 12, 2009
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  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:

U.S. FDA Resources

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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Vikram Kashyap, MD Cleveland Clinic Vascular Surgery
  More Information

No publications provided

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 May 23, 2013