Syncope Prediction Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Sensitivity of the Syncope Prediction Algorithm
研究概览
简要总结
The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.
详细描述
Vasovagal syncope (VVS) is a form of neurally-mediated reflex syncope, which is marked by a sudden fall in blood pressure with an associated fall in heart rate often resulting in syncope, head-up tilt (HUT) testing is commonly used to bring information about VVS using ECG and blood pressure monitoring with medical observation.
We developed an algorithm, called Tilt Test Analyzer, to predict VVS during HUT based on the simultaneous analysis of heart rate (RR interval), systolic blood pressure (SBP) and an indicator of autonomic modulation represented by heart rate and blood pressure variability (HRV and BPV).
The primary objective of this study is to evaluate the VVS prediction algorithm in a prospective cohort of patients in the tilt laboratory The primary endpoint is the VVS prediction algorithm performance by means of measuring the sensitivity and specificity values.
The study is designed to test if the prospective analysis of tilt-test patients can reproduce the results previously obtained in the published retrospective analysis on 1155 patients with a similar clinically relevant sensitivity and specificity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the center with vasovagal syncope for tilt testing.
- •The patient is willing and able to cooperate with the study procedures.
- •The subject or legal guardian is able to provide written informed consent
排除标准
- •Patients under 18 years or over 90 years old.
- •Women who are currently pregnant or have a positive pregnancy test.
- •Patients who had a prior tilt test.
- •Patients enrolled in another device or drug study.
结局指标
主要结局
Sensitivity of the Syncope Prediction Algorithm
时间窗: Tilt Test with average duration of 1 hour
Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm
Specificity of the Syncope Prediction Algorithm
时间窗: Tilt Test with average duration of 1 hour
Number of tilt-negative participants identified as negative by the syncope prediction algorithm
次要结局
未报告次要终点