Status:

COMPLETED

Endothelial Function in Human Arteries

Lead Sponsor:

The Cleveland Clinic

Conditions:

Endothelial Dysfunction

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief 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 as...

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 performe...

Eligibility Criteria

Inclusion

  • 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

  • acute limb ischemia,
  • contraindication to angiography (creatinine \>2.5)
  • concurrent oral anticoagulant therapy that cannot be safely withheld
  • extensive tissue loss or gangrene

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2011

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00848302

Start Date

September 1 2009

End Date

January 1 2011

Last Update

March 7 2017

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