Endothelial Function in Lower Extremity Bypass Grafts

Mass General Brigham

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Drug: L-N^G monomethyl arginine (L-NMMA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00759707

2006P-000424

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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19 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

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