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临床试验/CTRI/2019/08/020976
CTRI/2019/08/020976招募中不适用

A Non-interventional, Observational Study for potential early detection of Heart disease based on, data analytics, through extended monitoring of key body vitals using a finger wearable wireless device (a ring)

Omnyk India Private Limited1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Correlation of heart health and continuously monitored (24/7) key body vitals for extended period of time

研究概览

简要总结

A Non-interventional, Observational Study for potential earlydetection of Heart disease based on, data analytics, through extendedmonitoring of key body vitals.Clinical prediction model(CPM) developed based on long-term monitoring of Key body vitals has a goodpotential to develop a protocol with the capability to finetune it forpersonalized prediction. Using this model, we should be able to; increase theprobability of desired clinical outcomes, resulting in better care at reducedcosts for CVD patients.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients with a diagnosis for one of the cardiac ailments.
  • •Patient willing to sign the consent form.

排除标准

  • •Patients with acute illness needing critical care or having a definite psychiatric diagnosis.
  • •Pregnant women or nursing mothers.
  • •Patients with known skin allergies, or sensitivities to synthetic materials.
  • •Any patient, who in the opinion of the investigator, are unlikely to fulfill the study requirements.
  • •Patients currently enrolled in or are receiving investigational agents.
  • •Patients receiving pacing therapy (e.g., from a pacemaker);.

结局指标

主要结局

Correlation of heart health and continuously monitored (24/7) key body vitals for extended period of time

时间窗: 1, 3 , 6 and 9 months

次要结局

  • Development of predictive analysis Algorithms, enabling new guidelines for the care of heart patients.(6, 9, 12 and 15 months)

研究者

发起方
Omnyk India Private Limited
申办方类型
Other [Electronic Industry-Global]

研究点 (1)

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