Endothelial Function in Lower Extremity Bypass Grafts

NCT ID: NCT00759707

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-12-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein \[arterial\] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-NMMA.

Interventions

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

L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein \[arterial\] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-NMMA.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joshua A. Beckman, MD

Associate Professor of Medicine, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua A. Beckman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2006P-000424

Identifier Type: -

Identifier Source: org_study_id