Endothelial Function in Lower Extremity Bypass Grafts
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-N^G monomethyl arginine (L-NMMA)
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Arterial Disease focused on measuring saphenous vein bypass grafts, flow-mediated vasodilation
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.
Outcomes
Primary Outcome Measures
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00759707
First Posted
September 24, 2008
Last Updated
April 17, 2017
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00759707
Brief Title
Endothelial Function in Lower Extremity Bypass Grafts
Official Title
Endothelial Function in Lower Extremity Bypass Grafts
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
saphenous vein bypass grafts, flow-mediated vasodilation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Investigators who analyzed the results of vascular function testing were blinded to the participant identity.
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.
Intervention Type
Drug
Intervention Name(s)
L-N^G monomethyl arginine (L-NMMA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
Description
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.
Time Frame
Single visit study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua A. Beckman, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endothelial Function in Lower Extremity Bypass Grafts
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