Stroke in Egyptian Clinical REgisTry

• Conditions: Stroke Hemorrhagic; Stroke Spinal Cord; Stroke, Acute; Stroke, Complication; Stroke, Cardiovascular
• Interventions: Other: SECRET structured 5 bundles of standard healthcare services

• Registration Number: NCT03723382
• Lead Sponsor: Society of Minimally Invasive Neurological Therapeutic Procedures

Brief Summary

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

Detailed Description

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.

CFD for Best Medical Treatment Registry To investigate the possible application collected from CFD analysis in special situation to guide physician for best medical treatment (BMT) option for a Neurovascular Disorder.

Study Timeline

• Study Start: 2018-05-20
• Status Verified: 2018-10
• Study First Submitted: 2018-10-07
• Study First Submitted QC: 2018-10-25
• Last Update Submitted: 2018-10-25
• Study First Posted: 2018-10-29
• Last Update Posted: 2018-10-29
• Primary Completion: 2020-05-19
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with stroke with structured management	SECRET structured 5 bundles of standard healthcare services	Patients with the Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data

Primary Outcome Measures

Name	Time	Method
The National Institutes of Health Stroke Scale (NIHSS) reported	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	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	30 days post discharge from hospital	A ratio comparing the actual in-hospital mortality rate to the risk-adjusted expected mortality rate.

Secondary Outcome Measures

Name	Time	Method
Disease burden	1 year	Quality-Adjusted Life-Years (QALY) : measure of the life expectancy corrected for loss of quality of that life caused by diseases and disabilities.

Trial Locations

Locations (1)

Alexandria University , School of medicine , Neurology Department, Neurovascular Unit; 🇪🇬 Alexandria, Egypt