Stroke in Egyptian Clinical REgisTry (SECRET)

• ClinicalTrials.gov Identifier: NCT03723382
• Recruitment Status: Unknown
• First Posted: October 29, 2018
• Last Update Posted: October 29, 2018
• 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
• Information provided by (Responsible Party): Prof. Ossama Mansour, University of Alexandria

Study Description

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

Condition or disease	Intervention/treatment
Stroke, Cardiovascular; Stroke, Acute; Stroke Hemorrhagic; Stroke Spinal Cord; Stroke, Complication	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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 2 Years
• Official Title: Stroke in Egyptian Clinical REgisTry
• Actual Study Start Date: May 20, 2018
• Estimated Primary Completion Date: May 19, 2020
• Estimated Study Completion Date: July 30, 2020

Groups and Cohorts

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: Iv-Thrombolysis; Endovascular treatment; 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

Outcome Measures

Primary Outcome Measures :

1. The National Institutes of Health Stroke Scale (NIHSS) reported [ Time Frame: 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)
2. Modified Rankin Scale at Discharge [ Time Frame: 90 days post discharge from hospital ]
   Patients grouped by Modified Rankin Scale at discharge
3. Risk-Adjusted Mortality Ratio for Ischemic-Only and Ischemic and Hemorrhagic models [ Time Frame: 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 :

1. Disease burden [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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.

Contacts and Locations

Locations

Egypt

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

Alexandria, Egypt, 22121

Contact: ossama Mansour, MD,PhD,FNR 01223926932 yassinossama@yahoo.com

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: Farouk Talaat, 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

Sponsors and Collaborators

Society of Minimally Invasive Neurological Therapeutic Procedures

Egyptian Stroke Society

Egyptian Society of Neurological Surgeons

Egyptian Radiology Society

Middle East North Africa Stroke and Interventional Neurotherapies Organization

More Information

Additional Information:

registry website 

Egyptian Stroke Network -Alexandria Prototype 

Study Data/Documents: Clinical Study Report 

Identifier: StateData001
These are measures for national stroke measures in State Pool of data

• Responsible Party: Prof. Ossama Mansour, Prof of neurology alexandria university, University of Alexandria
• ClinicalTrials.gov Identifier: NCT03723382
• Other Study ID Numbers: ESS015000
• First Posted: October 29, 2018
• Last Update Posted: October 29, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: once start for 7 years
• Access Criteria: registred user to Site Data Non registered User to Stat Data
• URL: http://www.strokeregistry.eg

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Hemorrhagic Stroke; Myocardial Infarction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis