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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: April 17, 2017
Last verified: April 2017
September 24, 2008
April 17, 2017
April 2006
December 2009   (Final data collection date for primary outcome measure)
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation [ Time Frame: 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.
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation [ Time Frame: pre/post ischemic stimulus ]
Complete list of historical versions of study NCT00759707 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endothelial Function in Lower Extremity Bypass Grafts
Endothelial Function in Lower Extremity Bypass Grafts
This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Outcomes Assessor
Masking Description:
Investigators who analyzed the results of vascular function testing were blinded to the participant identity.
Primary Purpose: Basic Science
Peripheral Arterial Disease
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.
Experimental: 1
ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.
Intervention: Drug: L-N^G monomethyl arginine (L-NMMA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00759707
2006P-000424
Yes
Not Provided
No
Not Provided
Joshua A. Beckman, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
Brigham and Women's Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP