Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skeletal muscle perfusion during exercise stress
研究概览
简要总结
This study represents an important step to validate the use of contrast-enhanced ultrasound (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be used to accurately assess therapeutic improvements in tissue perfusion that are linked to symptom improvement.
详细描述
The study will be performed in patients with known history of PAD that are scheduled to undergo either surgical or percutaneous revascularization. Limb rest-stress CEU perfusion imaging will be performed before and 3-4 weeks after revascularization. Quantitative measurements of pre-revascularization perfusion, post-revascularization perfusion, and change in perfusion will be compared to symptom status (Rutherford classification and PAD [Criqui] questionnaire) at each study point, and to data on time to onset of claudication on an upright treadmill exercise study (Gardiner protocol). Results of angiography will be scored and allow determination of the relationship between angiographic severity of disease and exercise perfusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •History of symptomatic PAD
- •Rutherford score <6
- •Age ≥18 y.o.
- •Scheduled to undergo surgical or percutaneous revascularization
排除标准
- •Major medical illness affecting the limb other than PAD (muscle disease, neuromuscular disease, blood diseases).
- •Pregnant or lactating females (- HCG in women of child bearing age)
- •Hypersensitivity to any ultrasound contrast agent
- •Evidence right-to-left, bi-directional, or transient cardiac shunt; unexplained pulmonary hypertension (PA systolic pressure >40 mm Hg) or more than moderate reduction in left ventricular systolic function identified on screening echo.
- •Allergy to eggs
- •Inability to perform modest plantar flexion exercise
结局指标
主要结局
Skeletal muscle perfusion during exercise stress
时间窗: 1 month
Calf skeletal muscle perfusion will be assessed by contrast-enhanced ultrasound during calf raise exercise (every 3 seconds for 30 seconds). This assessment will be performed before and 3-4 weeks after revascularization.
次要结局
- Skeletal muscle perfusion at rest.(1 month)
研究者
Jonathan R. Lindner, MD
Professor
Oregon Health and Science University