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临床试验/CTRI/2024/09/074534
CTRI/2024/09/074534尚未招募不适用

Study of Arrhythmias and Biomarkers in Vulnerable Urban Dwellers to Assess Pathophysiological Nexus for Cardiovascular Outcomes

Monitra Healthcare Private limited1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年10月15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
800
试验地点
1
主要终点
Major Adverse Cardiovascular Event

研究概览

简要总结

INTERHEART Risk Score is a validated non laboratory measures based risk score for predicting new onset major acute cardiovascular events in general population. Combining this with a baseline holter monitoring for cardiac rhythm abnormalities and established biomarkers for cardiovascular disease, can improve our case detection for poor people living in urban settings. This study will give us important information on the prevalence of high risk population among the urban poor, the prevalence of a abnormal heart rhythm or a biomarker and their correlation to the incidence of major cardiovascular events over a period of 12 months.

The study is awaiting CTRI regsitration approval for recruiting patients into the cohort. The study will be initiated as soon as CTRI registration number is issued.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Non Laboratory INTERHEART Risk score above 10
  • Poor socio-economic urban living demography.

排除标准

  • known cardiac rhythm abnormalities.

结局指标

主要结局

Major Adverse Cardiovascular Event

时间窗: Major Adverse Cardiovascular Event

次要结局

  • Hospitalisation(12 months)
  • New onset Atrial Fibrillation(12 months)
  • New onset cardiac arrhythmia(12 months)

研究者

发起方
Monitra Healthcare Private limited
申办方类型
Other [Medical Device Company]
责任方
Principal Investigator
主要研究者

Dr Rajiv Kumar Bandaru

ESIC Medical College and Hospital

研究点 (1)

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