CTRI/2011/06/001811招募中不适用
Protocol: A-102 Assessment of Vascular Reactivity by Novel Diagnostic Device, ANGIOEF-3000, compared to that using Brachial Artery Ultrasound Imaging -- Initial Experience in an Indian Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Maximal percent flow-mediated dilation (%FMDmax) of the brachial artery
研究概览
简要总结
This is a non-invasive, open-label, randomized, comparative, cross-over, single-center investigational study comparing a novel diagnostic device, AngioEF-3000, to standard brachial artery ultrasound imaging for measuring flow-mediated dilation (FMD) of the brachial artery (BA). The primary outcome is maximal percent FMD (%FMDmax) of the BA; secondary outcome: intra-operator variability. Expected total enrollment: 45 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •ECOG/Zubrod score performance status 0-1 (ECOG 0: Fully active, able to carry on all pre-disease performance without restriction; ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work).
排除标准
- •Refractory atrial fibrillation or multifocal atrial tachycardia;Frequent ventricular or atrial premature contractions;Myocardial infarction or unstable angina within previous 90 d;Congestive heart failure;Significant valvular heart disease;15 mm Hg or greater difference in systolic blood pressure between R and L arms;History of axillary-subclavian venous thrombosis;Arteriovenous fistula for hemodialysis;History of lymph node dissection;Diabetes mellitus for which subject is receiving insulin;Vasospastic disorders manifested by Raynaud's phenomenon;Active viral or bacterial infection;Prescribed any new medication or had medication dose modification within previous 4 wks;Body mass index greater than 50 kg/m2.
结局指标
主要结局
Maximal percent flow-mediated dilation (%FMDmax) of the brachial artery
时间窗: %FMDmax is determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery
次要结局
- Intra-operator variability(Compare %FMDmax determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery on Study Day 1 with %FMDmax determined between 30 sec and 3 minutes after release of complete occlusion of the brachial artery on Study Day 8.)
研究者
研究点 (1)
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