Endothelial Function in Lower Extremity Bypass Grafts

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00759707
First received: September 24, 2008
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Peripheral Arterial Disease
Drug: L-N^G monomethyl arginine (L-NMMA)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Endothelial Function in Lower Extremity Bypass Grafts

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change from baseline in saphenous vein bypass graft vasodilation [ Time Frame: pre/post ischemic stimulus ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759707

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Joshua A. Beckman, MD, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00759707     History of Changes
Other Study ID Numbers: 2006P-000424
Study First Received: September 24, 2008
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
saphenous vein bypass grafts
flow-mediated vasodilation

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Omega-N-Methylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014