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Clinical Trials/NCT00759707
NCT00759707
Completed
Not Applicable

Endothelial Function in Lower Extremity Bypass Grafts

Brigham and Women's Hospital1 site in 1 country19 target enrollmentApril 2006

Overview

Phase
Not Applicable
Intervention
L-N^G monomethyl arginine (L-NMMA)
Conditions
Peripheral Arterial Disease
Sponsor
Brigham and Women's Hospital
Enrollment
19
Locations
1
Primary Endpoint
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow.

Detailed Description

Subjects who have undergone saphenous vein \[arterial\] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) Subjects will then be given sub-lingual nitroglycerin, and repeat ultrasound will be performed 3 minutes later. Following 10 minutes of rest, subjects will be given intravenous L-NMMA, a specific nitric oxide inhibitor, to help determine the responsible agent of the vein graft flow mediated dilation.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
December 2009
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joshua A. Beckman, MD

Associate Professor of Medicine, Harvard Medical School

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts

Exclusion Criteria

  • Amputation beyond the toes
  • Critical limb ischemia defined as rest pain, non-healing ulceration or gangrene
  • Pregnancy

Arms & Interventions

1

ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.

Intervention: L-N^G monomethyl arginine (L-NMMA)

Outcomes

Primary Outcomes

Change From Baseline in Saphenous Vein Bypass Graft Vasodilation

Time Frame: Single visit study

Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.

Study Sites (1)

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