Endothelial Function in Human Arteries

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Institutes of Health (NIH)
• Treatments: Nitric Oxide

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