Ultrasound Perfusion Estimation for Assessment of PAD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Detection of peripheral arterial disease using ultrasound perfusion estimation
研究概览
简要总结
The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient volunteers:
- •Male and Female, ages 18 years old and up
- •Symptom of claudication and suspected for PAD
- •Scheduled for vascular testing.
- •Healthy volunteers:
- •Male and female, ages 18-75 years old and up
- •Normal BMI
- •No history of smoking, cardiovascular disease, or diabetes.
排除标准
- •Patient volunteers:
- •Patients with gangrene
- •Patients having surgery or stent
- •Patients with ulcer on their leg
- •Any health condition that does not allow proper use of ultrasound scanning
- •People considered in "vulnerable" populations.
- •Healthy volunteers:
- •Include volunteers with BMI not more than 30
- •No history of smoking
- •No history of (diabetes, hypertension, cardiovascular diseases)
- •People considered in "vulnerable" populations.
研究组 & 干预措施
Study Group
Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD)
干预措施: Ultrasound Imaging (Diagnostic Test)
Healthy Volunteers
Healthy volunteers with normal ankle-brachial index (ABI)
干预措施: Ultrasound Imaging (Diagnostic Test)
结局指标
主要结局
Detection of peripheral arterial disease using ultrasound perfusion estimation
时间窗: Up to 4 years
Evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ultrasound perfusion estimation compared to a reference standard (e.g., ankle-brachial index \[ABI\], CT angiography, or MR angiography) in diagnosing PAD.
次要结局
- Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation(Up to 4 years)