NCT02682576已完成不适用
Brachial Artery Ultrasound Imaging: A Repeatability Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Change from baseline % flow-mediated dilation (%FMD) at 1 hour
研究概览
简要总结
The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, ≥18 years old
- •Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1)
- •Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study
排除标准
- •Body mass index (BMI) >50 kg/m2
- •Mid-upper arm circumference of arm selected for FMD testing <17 cm or >42 cm
- •Sinus arrhythmia (RR intervals vary by >50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
- •Clinical signs and/or symptoms of active viral or bacterial infections
- •Resting tremor or inability to remain still for the duration of the testing period
- •Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
- •Diabetic subjects - Type I or II
- •Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff
结局指标
主要结局
Change from baseline % flow-mediated dilation (%FMD) at 1 hour
时间窗: 1 hour
Repeat brachial artery ultrasound imaging of the same subject after 1 hour using the same operator and vascular ultrasound equipment
次要结局
- Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03(1 day)
研究者
研究点 (4)
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