Hemodynamic Biomarkers for Postural Tachycardia Syndrome Using a Novel Continuous Beat-to-Beat Wearable Blood Pressure Monitor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.
研究概览
简要总结
the investigators propose studies of a tiny, wearable, wireless, beat-to-beat blood pressure monitor that will be both a transformative research platform and an enabler of patient self-care in the diagnosis, investigation, and management of POTS.
详细描述
Detailed Description:
Project Purpose: the investigators propose studies of a tiny, wearable, wireless, beat-to-beat blood pressure monitor that will be both a transformative research platform and an enabler of patient self-care in the diagnosis, investigation, and management of POTS. The 2019 NIH POTS Consensus meeting stated the need for biomarkers that would i) provide physiologically-based diagnostic criteria; ii) be easily accessible and affordable; iii) reflect disease activity and response to treatment, and provide long-term outcome data; and iv) provide uniform phenotyping and a shared database for multicenter studies.
Current POTS heart rate (HR) diagnostic criteria may not reflect hemodynamic changes in daily life, and do not measure the underlining physiology, which is reduced stroke volume (SV) in most patients. Beat-to-beat blood pressure (BP) recordings with waveforms can derive SV. the investigators have developed an inexpensive, wearable, wireless, rechargeable, beat-to-beat BP monitor that sits behind the ear. It weighs 13 gm and samples the BP with high resolution waveforms. SV can be estimated from BP waveform shapes.
Research Objectives: the investigators hypothesize that SV 1) can be estimated from wearable BP monitors, and 2) will provide physiologic information for patients and physicians.
Aim 1: To determine the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing clinically indicated cardiac MRI
- •Between 18 and 80 years of age.
- •Able and willing to provide informed consent
排除标准
- •Somatization or severe anxiety symptoms will be excluded
- •Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
- •Unable to give informed consent
结局指标
主要结局
the accuracy of stroke volume estimated from a novel wearable BP monitor compared to that estimated from cardiac MRI.
时间窗: 10 minutes post-intervention( cardiac MRI)
that stroke volume can be accurately estimated based on ambulatory blood pressure and heart rate sequences and will diagnose POTS in patients at home, reflect clinical status, and be suitable for multicenter studies.
次要结局
未报告次要终点