Stroke in Egyptian Clinical REgisTry

NCT ID: NCT03723382

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-20

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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Stroke, Cardiovascular Stroke, Acute Stroke Hemorrhagic Stroke Spinal Cord Stroke, Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with stroke with structured management

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

SECRET structured 5 bundles of standard healthcare services

Intervention Type OTHER

THE 5 BUNDLES OF Stroke SERVICE They the mix of the services for stroke patient which are available at the SS EVT bundle: is the availability of the Endovascular services Telemedicine core bundle : is the ability to guide or guided via tele-medicine for decision making for stoke patients tPA core bundle : the availability of all infrastructure to administer tPA in the first 3 hours of onset (NNT=8) DISMAST bundle : which refer to the availability of Dysphagia detection and management ,Aspirin in hyper acute phase , The Mobilization plans and programs for the patients, anticoagulant and statin prescription for selected patients for secondary prophylaxis programs Process of care bundle : like registering patients and morphology of the disease, screening programs for risk factors , following primary prevention plans all bundles should be judged by the 8M approach

Patients with stroke without structured management

Control subject who have stroke and did not managed according to the SECRET 6 level metrics

No interventions assigned to this group

Interventions

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SECRET structured 5 bundles of standard healthcare services

THE 5 BUNDLES OF Stroke SERVICE They the mix of the services for stroke patient which are available at the SS EVT bundle: is the availability of the Endovascular services Telemedicine core bundle : is the ability to guide or guided via tele-medicine for decision making for stoke patients tPA core bundle : the availability of all infrastructure to administer tPA in the first 3 hours of onset (NNT=8) DISMAST bundle : which refer to the availability of Dysphagia detection and management ,Aspirin in hyper acute phase , The Mobilization plans and programs for the patients, anticoagulant and statin prescription for selected patients for secondary prophylaxis programs Process of care bundle : like registering patients and morphology of the disease, screening programs for risk factors , following primary prevention plans all bundles should be judged by the 8M approach

Intervention Type OTHER

Other Intervention Names

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Iv-Thrombolysis Endovascular treatment Rehabilitation , mobilization , bulbar care, secondary prevention Stroke unit calibration Prehospital care organization

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Stroke Society

OTHER

Sponsor Role collaborator

Egyptian Society of Neurological Surgeons

OTHER

Sponsor Role collaborator

Egyptian Radiology Society

OTHER

Sponsor Role collaborator

Middle East North Africa Stroke and Interventional Neurotherapies Organization

OTHER

Sponsor Role collaborator

Society of Minimally Invasive Neurological Therapeutic Procedures

NETWORK

Sponsor Role lead

Responsible Party

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Prof. Ossama Mansour

Prof of neurology alexandria university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University , School of medicine , Neurology Department, Neurovascular Unit

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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ossama Mansour, MD,PhD,FNR

Role: primary

01223926932

Related Links

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Other Identifiers

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ESS015000

Identifier Type: -

Identifier Source: org_study_id

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