Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Photoplethysmography amplitude
研究概览
简要总结
The investigators subjected 63 patients (39 with typical Cold urticaria and 24 with atypical Cold urticaria ) and 15 healthy controls to TempTest® cold stimulation tests and critical temperature threshold assessments. Blood microcirculation photoplethysmography measurements were performed 5 min before and 10 min after the ice cube on the volar forearm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cold urticaria
排除标准
- 未提供
研究组 & 干预措施
Typical ColdU
39 patients had typical ColdU confirmed by positive ICT and TempTest® CSTs.
干预措施: Cold stimulation tests / critical temperature threshold (Device)
Atypical ColdU
24 patients had atypical ColdU with negative ICT and TempTest® CSTs.
干预措施: Cold stimulation tests / critical temperature threshold (Device)
Control group
15 healthy controls (HCs) who had no history of pathological reactions associated with cold exposure, and all of them had negative CSTs
干预措施: Cold stimulation tests / critical temperature threshold (Device)
结局指标
主要结局
Photoplethysmography amplitude
时间窗: 10 min after the end of cold exposure
To compute the blood flow signal, we subtracted slowly time-varying background and frequency components out of the cardiovascular-related range of 0.3-7 Hz. The resulting well-matched, noise-free and intensity-corrected blood flow images are suited for PPG calculation by averaging the intensity pixel values of each frame. The PPG amplitude is proportional to the amount of arterial blood that reaches the visualized skin area and thus characterizes its blood perfusion. It is measured in arbitrary units (AU). We performed photoplethysmographic assessments of the volar forearm of all patients 5 minutes before and 10 minutes after the beginning and end of ice cube application.
次要结局
未报告次要终点
研究者
Daria Fomina
Head of the Center of Allergy and Immunology
City Clinical Hospital No.52 of Moscow Healthcare Department