Endothelial Function in Lower Extremity Bypass Grafts

NCT00759707 | Completed Results DMC

• 1 other identifier: 2006P-000424
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

saphenous vein bypass grafts; flow-mediated vasodilation

Outcome Measures

Primary Outcomes (1)

• 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.

  Single visit study

Study Arms (1)

1

EXPERIMENTAL

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)

Interventions

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts

You may not qualify if:

• Amputation beyond the toes
• Critical limb ischemia defined as rest pain, non-healing ulceration or gangrene
• Pregnancy

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

omega-N-Methylarginine

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Results Point of Contact

• Title: Dr. Joshua Beckman
• Organization: Brigham and Women's Hospital

jbeckman@partners.org

6175257053

Study Officials

• Joshua A. Beckman, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators who analyzed the results of vascular function testing were blinded to the participant identity.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: April 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 16, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)