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Endothelial Function in Lower Extremity Bypass Grafts

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00759707
First received: September 24, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
 Procedure: ultrasound imaging

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2009
Estimated 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.
 Procedure: ultrasound imaging
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, M.D., Principal Investigator, 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: September 24, 2008
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

ClinicalTrials.gov processed this record on May 23, 2013