跳至主要内容
临床试验/NCT04383522
NCT04383522Unknown不适用

National Registry of Epilepsy in Mexico

Programa Prioritario de Epilepsia0 个研究点目标入组 15,000 人开始时间: 2020年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15,000
主要终点
To know the type of epileptic crisis, the type of epilepsy and the type of epileptic syndrome presented by patients who are treated for this disease in 70 public hospitals in the health sector in Mexico.

研究概览

简要总结

The National Registry of Epilepsy in Mexico aims to be an observational, multicenter, and nationwide study about Epilepsy in Mexico. This project is proposed as the first registry about the diagnosis and treatment of epilepsy in Mexico. The participation of major health institutions, both public and private, of each state to ensure that the registry is representative of the country is planned.

详细描述

Introduction Epilepsy is a brain chronic condition characterized by the recurrence of unprovoked motor and non-motor seizures. A seizure can be defined as the transient appearance of signs and/or symptoms due to excessive abnormal neuronal activity in the brain.

The International League against Epilepsy (ILAE) proposes that epilepsy should be considered a brain disease based on at least one of the following conditions: (1) at least two unprovoked (or reflex) seizures occurring more than 24 hours apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next ten years; (3) diagnosis of an epilepsy syndrome.

Epilepsy is one of the most common neurological diseases worldwide, affecting around 60 million people of all ages around the world. The risk of premature death in people with epilepsy is up to three times that of the general population. The lives of people with epilepsy are often impacted by stigma, discrimination, and human rights violations.

Nearly 80% of people with epilepsy live in low- and middle-income countries (LMIC), where treatment gaps exceed 75% in most low-income countries and 50% in most middle-income countries. Unfortunately, the lack of epidemiological registries about this disease makes early diagnosis and effective treatment difficult, thus increasing its prevalence.

Design and methods The National Registry of Epilepsy in Mexico aims to be an observational, multicenter, and nationwide study about Epilepsy in Mexico. This project is proposed as the first registry about the diagnosis and treatment of epilepsy in Mexico. The participation of major health institutions, both public and private, of each state to ensure that the registry is representative of the country is planned. It seeks for wide geographical distribution to compare the quality of care between the different geographical areas of the country.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To know the type of epileptic crisis, the type of epilepsy and the type of epileptic syndrome presented by patients who are treated for this disease in 70 public hospitals in the health sector in Mexico.

时间窗: Four months

We have a database that will be used to capture patients divided by type of epileptic crisis that they present, both focal onset, generalized onset, or unknown onset. By the type of epilepsy that they present either focal, generalized, mixed, both focal and generalized or unknown epilepsy. And those who present characteristics of an epileptic syndrome register them. In this way we will have absolute numbers for each category of these three items.

To know the type of antiepileptic drugs that have been used and are currently used by patients treated for Epilepsy in 70 public hospitals in the health sector in Mexico.

时间窗: Four months

We have a database that will be used to capture the drugs previously used by patients with epilepsy and what has been the reason for not taking them anymore, either due to lack of effectiveness or adverse effect, indicating by devices and systems in where it presented the adverse effect. In the same way, the antiepileptic drugs used by patients with epilepsy to control their disease will be known and accounted for.

Number of patients treated for epilepsy in 70 public hospitals in the health sector in Mexico, divided by age groups.

时间窗: Four months

We have a database that will be used to capture patients separated by age, newborn, pediatric age and adults, analyzing how many belong to each age group with an individual accounting to know the total absolute number.

Number of patients with epilepsy, separated by etiologies treated in 70 public hospitals in the health sector in Mexico.

时间窗: Four months

We have a database that will be used to capture patients separated by six specific etiologies, as currently recommended by the International League Against Epilepsy, structural, genetic, immune, infectious, metabolic or unknown, accounting for those who register each group to know the total absolute number.

To know the type of comorbidity presented by patients treated for Epilepsy in 70 public hospitals in the health sector in Mexico.

时间窗: Four months

We have a database that will be used to capture the different comorbidities that patients present, some of them may have more than one comorbidity and it is interesting to quantify which are the most frequent of this group of patients treated in hospitals in the sector. public from Mexico regardless of the age of the patient, although later a more frequent sub-analysis can be made by age group and comorbidity.

Number of patients in spatial groups such as those in the newborn, pregnancy, with epilepsy surgery and with concomitant diseases treated by Epilepsy in 70 public hospitals in the health sector in Mexico.

时间窗: Four months

We have a database that will be used to capture patients separated by age, newborn, pediatric age and adults, analyzing how many belong to each age group with an individual accounting to know the total absolute number.

次要结局

未报告次要终点

研究者

发起方
Programa Prioritario de Epilepsia
申办方类型
Other
责任方
Sponsor

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