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临床试验/NCT03723382
NCT03723382Unknown不适用

Stroke in Egyptian Clinical REgisTry

Society of Minimally Invasive Neurological Therapeutic Procedures1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2018年5月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50,000
试验地点
1
主要终点
The National Institutes of Health Stroke Scale (NIHSS) reported

研究概览

简要总结

This is a multi-institutional registry database for the patients with stroke and cerebrovascular diseases. Stroke is the second leading cause of death in the Egypt. Despite extensive research, most of the patients die or suffer from varying degree of post-stroke disabilities due to neurologic deficits.

This registry aims to understand the disease and examine the disease dynamics at the National Level. additionally it aim to introduce an objective method for classifying the registered hospital on a spectrum of 6 level coded with colors (from Black to Green ) according the availability of the predetermined 5 bundles of services presented for patient

详细描述

A clinical registry is an observational database, usually focusing on a clinical condition, procedure, therapy, or population. A stroke registry can be defined as "an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual patients who have had a stroke".

An ideal stroke registry is nationwide and enrolls patients from as many participating hospitals as possible in order to increase representativeness and avoid selection bias. For example, the Risk-Stroke register in Sweden, launched in 1994, has covered all hospitals that admit acute stroke patients across the country since 1998 . Appropriate data structure and governance policies are needed to keep a nationwide stroke registry sustainable and operating well. Through the publication and communication of results, a stroke registry should be helpful for improvement of stroke care quality, health policy, and the outcomes of patients.

SECRET registry aim to help in the following

  1. National Grading of The Presented Stroke Care Services:

where A 6 levels grading system was designed according to the capability of each service spot (hospital, center, etc.) to present a range of the 5 stroke service bundles of care. each Service Spot (SS) will have one of the following colors according to the availability of the services. 2. Cost-effectiveness registry Based SOPs SECRET is the first of its type registry to study the parameters for cost/effectiveness analysis for specific steps in the chain of care for stroke patient. The only convincing tool which could be used to approach the politics to be attentive and malleable for changing national plans of healthcare. 3. Aneurysm Registry This Part of the registry is dedicated for the cerebral aneurysm disorders and their type of clinical presentation. The options of treatment and each option effectiveness and cost outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with a diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis seen in the registered Centers.
  • Age > 1 years of age.

排除标准

  • Patients who don't have the diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis.
  • Patients who have Epidural Hematoma, Subdural hematoma.

结局指标

主要结局

The National Institutes of Health Stroke Scale (NIHSS) reported

时间窗: 30 days post discharge from hospital

Severity of ischemic stroke and stroke not otherwise specified patients will be weighted with a score reported for NIH Stroke Scale will be grouped into Mild stroke (\>0-6 on NIHSS) moderate (\>6 - 10 on NIHSS) severe (\>10 - 20 on NIHSS) and Grave (\>20 on NIHSS)

Modified Rankin Scale at Discharge

时间窗: 90 days post discharge from hospital

Patients grouped by Modified Rankin Scale at discharge

Risk-Adjusted Mortality Ratio for Ischemic-Only and Ischemic and Hemorrhagic models

时间窗: 30 days post discharge from hospital

A ratio comparing the actual in-hospital mortality rate to the risk-adjusted expected mortality rate.

次要结局

  • Disease burden(1 year)

研究者

发起方
Society of Minimally Invasive Neurological Therapeutic Procedures
申办方类型
Network
责任方
Principal Investigator
主要研究者

Prof. Ossama Mansour

Prof of neurology alexandria university

University of Alexandria

研究点 (1)

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