Clinical trial NCT03723382: Stroke in Egyptian Clinical REgisTry
Official title: Stroke in Egyptian Clinical REgisTry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Cardiovascular
Stroke, Acute
Stroke Hemorrhagic
Stroke Spinal Cord
Stroke, Complication
Lead sponsor: Society of Minimally Invasive Neurological Therapeutic Procedures
Sponsor class: NETWORK
Collaborators: name: Egyptian Stroke Society
name: Egyptian Society of Neurological Surgeons
name: Egyptian Radiology Society
name: Middle East North Africa Stroke and Interventional Neurotherapies Organization
First posted: 2018-10-29
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a final/discharge diagnosis of stroke or transient ischemic attack can be included into the SECRET Registry.

This includes cases with a principal/primary or secondary diagnosis of:

Cerebral Infarction Intracerebral Hemorrhage (non-traumatic) Ischemic Stroke Subarachnoid Hemorrhage (non-traumatic) Transient Ischemic Attack (TIA) Cerebral Venous Sinus Thrombosis The investigators will use the available EMR and databases to search for these patients using relevant ICD-9/10 codes. or any other method used internally to archive stroke cases

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The National Institutes of Health Stroke Scale (NIHSS) reported
timeFrame: 30 days post discharge from hospital
measure: Modified Rankin Scale at Discharge
timeFrame: 90 days post discharge from hospital
measure: Risk-Adjusted Mortality Ratio for Ischemic-Only and Ischemic and Hemorrhagic models
timeFrame: 30 days post discharge from hospital
Secondary outcomes:
measure: Disease burden
timeFrame: 1 year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
Study officials:
References: