Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device Compared With 24-hour Ambulatory Blood Pressure Monitoring Device: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The average agreement between blood pressure measured with a 24-hour ambulatory BP measurement device and blood pressure measured with a ring-type BP measurement device during a subject's activity time.
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. The main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. To participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension
- •Confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes
- •Either criterion 1 or 2 are planned to be selected as study participants.
排除标准
- •Participants who do not consent to the study
- •Individuals with a Body Mass Index of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well)
- •Pregnancy
- •Baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction
- •Patients diagnosed with atrial fibrillation on a 12 lead EKG within the past 6 months
- •End-stage renal disease (patients undergoing dialysis)
- •Users of mobile phones that are not compatible with the test device (CART-I plus) used in the study
结局指标
主要结局
The average agreement between blood pressure measured with a 24-hour ambulatory BP measurement device and blood pressure measured with a ring-type BP measurement device during a subject's activity time.
时间窗: Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring.
次要结局
未报告次要终点
研究者
Hae-young Lee
Head of Cardiology
Seoul National University Hospital