Trial Outcomes & Findings for Endothelial Function in Lower Extremity Bypass Grafts (NCT NCT00759707)

NCT ID: NCT00759707

Last Updated: 2017-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Single visit study
• Results posted on: 2017-05-16

Participant Flow

Participant milestones

Measure	Study Population All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N\^G monomethyl arginine (L-NMMA) was administered intravenously.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endothelial Function in Lower Extremity Bypass Grafts

Baseline characteristics by cohort

Measure	Study Population n=19 Participants All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N\^G monomethyl arginine (L-NMMA) was administered intravenously.
Age, Continuous	64.7 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Study Population n=19 Participants All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N\^G monomethyl arginine (L-NMMA) was administered intravenously.
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation	5.28 vein bypass graft size increase (%) Standard Error 3.1

Adverse Events

Study Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joshua Beckman

Brigham and Women's Hospital

Phone: 6175257053

Email: jbeckman@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place