跳至主要内容
临床试验/CTRI/2017/10/010097
CTRI/2017/10/010097进行中(未招募)不适用

Registry of Atrial Fibrillation in Kerala: A Multicentre cohort study.

Cardiological Society of India Kerala Chapter65 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,000
试验地点
65
主要终点
Peripheral embolism

研究概览

简要总结

Background

Kerala was held up to the world as ‘good health at low cost’. Human development index (HDI) for Kerala is highest in India. Geographically Kerala is situated at the south-west tip of India with an estimated population of 34 million.

Atrial fibrillation (AF) is the most common form of chronic cardiac arrhythmia and its prevalence is likely to increase in the next decades. AF is independently associated with increased risk of stroke and death. AF is associated with a six fold increase in stroke risk, contributing 20-25% of ischaemic stroke in older patients. The incidence of AF doubles with successive age decades after the age of 50 years. Hypertension is the most common comorbidity in AF patients, and globally there has been a steady increase in hypertension prevalence in AF patients from 53% to 83% over the last 20 years.

Very little is known about the prevalence, aetiology and treatment pattern of AF in India and continued data collection through a registry can improve understanding of AF in India. In some rural parts of India, Rheumatic heart disease (RHD) had been reported as the most common factor for AF. In Kerala it has been observed that hypertension is the important factor leading to AF, just like that in the western countries. Though this transition is well appreciated in Kerala, it is not documented through scientific study.

Rationale

Data on Atrial Fibrillation patients from the State of Kerala is lacking. This study will be initiated as state-wide patient registry to document the etiology and socio demographic characteristics of AF patients in the state and the current standard of care as well as short to medium term mortality rate of  AF patients in Kerala.  All patients will be followed up at 30 days, 6 months and 1,2,3,4 and 5 years, for clinical outcome. A database will be created for further scientific study to improve treatment for AF in Kerala.

Clinical Outcome:  Cardiovascular death,

Stroke or transient ischemic attack,

Myocardial infarction,

Peripheral embolism

Hospitalization for arrhythmia,

Hospitalization for: cardiovascular events or intervention, chronic heart failure, acute coronary syndrome.

Primary Objective: To evaluate the cardiovascular and non-cardiovascular diseases associated with AF and to assess the socio-demographic characteristics of AF patients.

Secondary Objectives:

1.      To estimate the mortality rates among patients with AF in the state.

2.      To estimate the incidence of major adverse cardiac and cerebrovascular  events (MACCE) in patients with AF.

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.All newly diagnosed and existing cases with ECG evidence of AF 2.Patients above 18 years.

排除标准

  • 1.Transient AF due to reversible causes like Acute Myocardial Infarction, Infection, Metabolic abnormalities, Alcoholic Intoxication and post-operative.
  • 2.Critically ill patients with life expectancy less than 30 days.

结局指标

主要结局

Peripheral embolism

时间窗: 1 year

Myocardial infarction,

时间窗: 1 year

Cardiovascular death,

时间窗: 1 year

Hospitalization for: cardiovascular events or intervention, chronic heart failure, acute coronary syndrome

时间窗: 1 year

Stroke or transient ischemic attack,

时间窗: 1 year

Hospitalization for arrhythmia,

时间窗: 1 year

次要结局

  • 1.To estimate the mortality rates among patients with AF in the state.(2.To estimate the incidence of major adverse cardiac and cerebrovascular events (MACCE) in patients with AF.)

研究者

申办方类型
Other [Society of Cardiologists]

研究点 (65)

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