Endothelial Function in Lower Extremity Bypass Grafts

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: L-N^G monomethyl arginine (L-NMMA)

• Registration Number: NCT00759707
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2016-12-08
• Results First Submitted QC: 2017-02-22
• Status Verified: 2017-04
• Results First Posted: 2017-04-06
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	L-N^G monomethyl arginine (L-NMMA)	ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States