Endothelial Function in Human Arteries - Full Text View

Sponsors and Collaborators:	The Cleveland Clinic National Institutes of Health (NIH)
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00848302

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 I

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Endothelial Function in Human Arteries

Resource links provided by NLM:

Drug Information available for: Arginine Arginine hydrochloride

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 ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
L-arginine: Experimental 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

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

Contacts

Contact: Sonya Parker	216/445-6321	parkers2@ccf.org
Contact: Harris Sandra	216/444-5896	harriss@ccf.org

Locations

United States, Ohio
Cleveland Clinic Vascular Surgery	Recruiting
Cleveland, Ohio, United States, 44195

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:	Cleveland Clinic--Vascular Surgery ( Dr. Vikram Kashyap )
Study ID Numbers:	K23HLOBO247, K23HLOBO247
Study First Received:	February 12, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00848302 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

peripheral vascular disease
endothelial dysfunction
intravascular ultrasound
L-Arginine

Study placed in the following topic categories:

Nitric Oxide
Peripheral Vascular Diseases
Arginine
Vascular Diseases

ClinicalTrials.gov processed this record on August 30, 2009