Stroke in Egyptian Clinical REgisTry

Stroke, Acute Clinical Trial

— SECRET  

Official title:

Stroke in Egyptian Clinical REgisTry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03723382
• Other study ID #: ESS015000
• Status: Recruiting
• Start date: May 20, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: October 2018
• Source: Society of Minimally Invasive Neurological Therapeutic Procedures
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: July 30, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Infarction
• Stroke
• Stroke Hemorrhagic
• Stroke Spinal Cord
• Stroke, Acute
• Stroke, Cardiovascular
• Stroke, Complication

Intervention

Other:
• 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

Locations

Country	Name	City	State
Egypt	Alexandria University , School of medicine , Neurology Department, Neurovascular Unit	Alexandria

Sponsors (5)

Lead Sponsor	Collaborator
Society of Minimally Invasive Neurological Therapeutic Procedures	Egyptian Radiology Society, Egyptian Society of Neurological Surgeons, Egyptian Stroke society, Middle East North Africa Stroke and Interventional Neurotherapies Organization

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The National Institutes of Health Stroke Scale (NIHSS) reported	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)	30 days post discharge from hospital
Primary	Modified Rankin Scale at Discharge	Patients grouped by Modified Rankin Scale at discharge	90 days post discharge from hospital
Primary	Risk-Adjusted Mortality Ratio for Ischemic-Only and Ischemic and Hemorrhagic models	A ratio comparing the actual in-hospital mortality rate to the risk-adjusted expected mortality rate.	30 days post discharge from hospital
Secondary	Disease burden	Quality-Adjusted Life-Years (QALY) : measure of the life expectancy corrected for loss of quality of that life caused by diseases and disabilities.	1 year

External Links

•   Egyptian Society of Neurological Surgeons
•   Egyptian Stroke Network -Alexandria Prototype
•   registry website