Augmentation of Limb Perfusion With Contrast Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in blood flow at 10 min
研究概览
简要总结
Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 y.o.
- •For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.
排除标准
- •Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV or LVEF <30%]).
- •Pregnant or lactating females
- •Hypersensitivity to any ultrasound contrast agent
- •Known atrial septal defect or large right to left shunt.
- •Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors)
- •Evidence for ongoing myocardial ischemia
- •For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
结局指标
主要结局
Change in blood flow at 10 min
时间窗: 10 min post-therapeutic ultrasound cavitation.
Change in blood flow in calf skeletal muscle
Change in blood flow at 60 min
时间窗: 60 min post-therapeutic ultrasound cavitation
Change in blood flow in calf skeletal muscle
次要结局
未报告次要终点
研究者
Jonathan R. Lindner, MD
Professor
Oregon Health and Science University