Endothelial Function in Lower Extremity Bypass Grafts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
研究概览
简要总结
This study will determine whether or not saphenous vein [arterial] bypass grafts in the leg relax in response to increases in blood flow.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Investigators who analyzed the results of vascular function testing were blinded to the participant identity.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts
排除标准
- •Amputation beyond the toes
- •Critical limb ischemia defined as rest pain, non-healing ulceration or gangrene
- •Pregnancy
研究组 & 干预措施
1
ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.
干预措施: L-N^G monomethyl arginine (L-NMMA) (Drug)
结局指标
主要结局
Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
时间窗: 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.
次要结局
未报告次要终点
研究者
Joshua A. Beckman, MD
Associate Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital