Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Change from baseline %flow-mediation dilation (%FMD) at 1 hour
研究概览
简要总结
The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.
Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator.
Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.
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, 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 muscle 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
研究组 & 干预措施
AngioDefender
The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound.
干预措施: AngioDefender (Device)
结局指标
主要结局
Change from baseline %flow-mediation dilation (%FMD) at 1 hour
时间窗: Daily x 4 consecutive days
Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day)
次要结局
- Reproducibility of multiple %FMD determinations by AngioDefender(Daily x 4 consecutive days)
- Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03(4 consecutive days (maximum 5 days))