CTRI/2025/07/091698尚未招募不适用
Validation of a heart health monitoring device in individuals with and without cardiovascular risk factors
Connected Health, TATA Industries Limited1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation between heart rate HR ECG parameters blood pressure variation and oxygen saturation SpOtwo values obtained using the heart health monitoring device and gold standard methods such as 12-lead ECG
研究概览
简要总结
This study aims to assess the performance of the heart health monitoring device in individuals with and without cardiovascular risk factors by comparing the results with Gold standards
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting adults of any gender in 3 categories with 50:50 ratio of males and females who fulfils atleast one of the following criteria a.
- •Healthy individuals with no risk for CVD b.
- •Patients with risk for CVD (DM, HT, dyslip) without a CVD event (stroke, MI, HF, PAD) c.
- •Patients who had a vascular event (MI or stroke) in the last one year.
排除标准
- •a.Critically ill patients b.
- •Patients with cognitive impairment.
- •Patients and volunteers above 65 years age.
- •Pregnant and Lactating women.
结局指标
主要结局
Correlation between heart rate HR ECG parameters blood pressure variation and oxygen saturation SpOtwo values obtained using the heart health monitoring device and gold standard methods such as 12-lead ECG
时间窗: At baseline
次要结局
- Consistency of the devices readings across repeated measurements within the same individual under similar conditions Intraclass correlation coefficients for assessing reliability(At Baseline)
研究者
Dr Denis Xavier
St. Johns Health Innovation Foundation
研究点 (1)
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