Endothelial Function in Human Arteries

Endothelial Dysfunction Clinical Trial

Official title:

Endothelial Function in Human Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848302
• Other study ID #: K23HLOBO247
• Secondary ID: K23HLOBO247
• Status: Completed
• Phase: Early Phase 1
• First received: February 12, 2009
• Last updated: March 6, 2017
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local arterial factors including peripheral L-arginine and nitrotyrosine levels via mass spectrometry and morphologic parameters of plaque composition.		Procedural