跳至主要内容
临床试验/CTRI/2018/10/016055
CTRI/2018/10/016055尚未招募不适用

Population based prevalence study of Atrial Fibrillation in Rural Andhra Pradesh

Boehringer Ingelheim India Private Limited1 个研究点 分布在 1 个国家目标入组 11,021 人开始时间: 2018年10月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
11,021
试验地点
1
主要终点
Not applicable. Presence of Atrial Fibrillation on ECG is considered as a case for this prevalence study.

研究概览

简要总结

This is a population-based prevalence study of Atrial Fibrillation in Rural Andhra Pradesh. The main objectives of the study are to assess the prevalence of atrial fibrillation in the adult population of rural areas of East and West Godavari Districts and, to study its cardiovascular risk profile. Undetected or suboptimally treated patients with atrial fibrillation are at high risk for stroke. The study aims to assess the burden of the condition and also understand the population’s health profile to understand the factors affecting the diagnosis of the condition and its optimal management. Sampling will be done in two stages: Forty villages in the two districts will be selected by Probability Proportional to Size sampling method. In the second stage, individuals aged 18 years and above will be selected by age and sex-stratified by simple random sampling. The study will be conducted on 11,021 participants.

The study will be done in two stages. In stage 1-on Day 1, using a door-to-door survey method, basic information such as anthropometric measurements, cardiovascular risk factors, awareness of cardiovascular risk, health-seeking behaviour and medical history will be collected. ECG will be recorded for all participants using a Smartphone compatible, hand-held ECG machine. On Day 2, fasting blood samples for glucose and lipid profile will be drawn. During stage 2, patients identified with atrial fibrillation by ECG will be further assessed for etiology for AF (using echocardiogram), risk factors for stroke and treatment (if any) adequacy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Men and women aged eighteen years and above 2.Willing to participate in the study by signing the informed consent form.

排除标准

  • 1.Individuals not willing to participate in the study.
  • 2.Individuals who are not resident of the selected villages.
  • 3.Individuals who haven’t followed instructions for blood glucose testing.

结局指标

主要结局

Not applicable. Presence of Atrial Fibrillation on ECG is considered as a case for this prevalence study.

时间窗: The study would end approximately in Febrauary 2019

次要结局

  • Not applicable(Not applicable)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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