Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 10
- 主要终点
- Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
研究概览
简要总结
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •Body mass index (BMI) >50 kg/m2
- •Mid-upper arm circumference of arm selected for FMD testing <17 cm or >40 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 AD and BAUI testing
- •Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
- •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 BA occlusion by a standard upper arm sphygmomanometric blood pressure (BP) cuff. The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis.
干预措施: AngioDefender (Device)
Brachial Artery Ultrasound Imaging
A non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery (BA) using high resolution continuous ECG-gated B-mode (2D) ultrasound imaging during reactive hyperemia, a state of transient increase in tissue blood flow that occurs following a brief period of ischemia, e.g., BA occlusion. BA diameter is measured at end-diastole, coincident with the R wave of a simultaneously recorded ECG.
干预措施: Ultrasound (Device)
结局指标
主要结局
Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
时间窗: 1 day
Deming regression analysis and Bland-Altman Plots
次要结局
- Comparison of types and incidences of emergent adverse device effects(1 day)