Stroke in Egyptian Clinical REgisTry (SECRET)

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

Study Overview

• Status: Unknown
• Conditions: Stroke, Acute; Stroke Hemorrhagic; Stroke, Cardiovascular; Stroke, Complication; Stroke Spinal Cord
• Intervention / Treatment: Other: SECRET structured 5 bundles of standard healthcare services

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 Type: Observational
• Enrollment (Anticipated): 50000

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 22121
    • Recruiting
    • Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
    • Contact: ossama Mansour, MD,PhD,FNR; Phone Number: 01223926932; Email: yassinossama@yahoo.com
    • Principal Investigator: Farouk Talaat, MD
    • Principal Investigator: Ashraf Abdo, MD,PhD,FNR
    • Sub-Investigator: Ismail Ramadan, Msc
    • Sub-Investigator: Amro ElFatatry, MS
    • Principal Investigator: Saher Hashim, MD,PhD
    • Principal Investigator: Azza Ghali, MD
    • Principal Investigator: Eman Khedr, MD
    • Principal Investigator: Aymen Nassif, MD
    • Principal Investigator: Khalid Sobh, MD
    • Principal Investigator: Fathi afifi, MD
    • Principal Investigator: Tarek Meniece, MD
    • Principal Investigator: Sameh Saeed, MD
    • Principal Investigator: Hazem Marouf, MD
    • Principal Investigator: Hany Eldeeb, MD
    • Principal Investigator: Mohamed Abdallah, MD
    • Principal Investigator: Khalid Marouf, MD
    • Principal Investigator: Sayed Tag eldeen, MD
    • Principal Investigator: Farouk Hassen, MD
    • Principal Investigator: Ahmed Elserwi, MD
    • Principal Investigator: Tamer Hassen, MD
    • Principal Investigator: Mohamed Khalid, MD
    • Principal Investigator: Hany Zakieldeen, MD
    • Principal Investigator: Mostafa Mahmoud, MD
    • Principal Investigator: Amero Mahmoud, MD
    • Principal Investigator: Mohamed Alaa, MD
    • Principal Investigator: Ahmed Aboelhassen, MD
    • Principal Investigator: Islam Ismail, MD
    • Principal Investigator: Islam El-malki, MD
    • Principal Investigator: Ahmed El-nemr, MD
    • Principal Investigator: islam el-desoky, MD
    • Principal Investigator: Ossama Mansour, MD
    • Principal Investigator: Abeer Bekheet, MD
    • Principal Investigator: Wael elshawaf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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; Other Names: Endovascular treatment; Iv-Thrombolysis; Rehabilitation , mobilization , bulbar care, secondary prevention; Stroke unit calibration; Prehospital care organization
Patients with stroke without structured management; Control subject who have stroke and did not managed according to the SECRET 6 level metrics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Modified Rankin Scale at Discharge	Patients grouped by Modified Rankin Scale at discharge	90 days post discharge from hospital
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Society of Minimally Invasive Neurological Therapeutic Procedures
• Collaborators: Egyptian Stroke Society; Egyptian Society of Neurological Surgeons; Egyptian Radiology Society; Middle East North Africa Stroke and Interventional Neurotherapies Organization

Publications and helpful links

Helpful Links

• registry website
• Egyptian Stroke Network -Alexandria Prototype

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2018
• Primary Completion (Anticipated): May 19, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Myocardial Infarction; Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: ESS015000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: once start for 7 years
• IPD Sharing Access Criteria: registred user to Site Data Non registered User to Stat Data
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Study Data/Documents

1. Clinical Study Report
   Information identifier: StateData001
   Information comments: These are measures for national stroke measures in State Pool of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No