Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
试验速览
- 阶段
- 2 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles
研究概览
简要总结
The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Healthy controls: no active major medical problems or vasoactive medications
- •For PAD: Known diagnosis with PAD an ABI of 0.4-0.6
排除标准
- •Rutherford class 6 or greater
- •Allergy to ultrasound contrast agents
- •Previous limb amputation
- •Pregnancy
- •Known congenital or acquired right to left shunt
研究组 & 干预措施
Healthy subjects
Intervention: administration of ultrasound contrast agent (drug) to assess muscle perfusion. Normal healthy subjects (n=10) will be used for optimization of dose and acoustic settings for performing real-time contrast ultrasound perfusion imaging of the limb.
干预措施: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging) (Drug)
Patients with PAD and ABI 0.4-0.6
Intervention: administration of ultrasound contrast agent (drug) to assess muscle perfusion. Patients with moderate to severe PAD (ABI 0.4 to 0.6) will be evaluated with contrast ultrasound perfusion imaging using methods optimized in the first Arm to determine whether symptoms better correlate with perfusion imaging than other measures of PAD severity.
干预措施: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging) (Drug)
Patients with PAD Undergoing Revascularization
Intervention: administration of ultrasound contrast agent (drug) to assess change in muscle perfusion produced by revascularization (surgical or percutaneous procedure). Patients with symptomatic PAD will be evaluated with contrast ultrasound perfusion imaging using methods optimized in the first Arm before and within 1 month of revascularization to determine whether improvement in symptoms correlate with perfusion imaging data.
干预措施: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging) (Drug)
结局指标
主要结局
Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles
时间窗: 5 minutes
次要结局
未报告次要终点
研究者
Jonathan R. Lindner, MD
Professor
Oregon Health and Science University