Stroke in Egyptian Clinical REgisTry
SECRET
1 other identifier
observational
50,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2018
CompletedFirst Submitted
Initial submission to the registry
October 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedOctober 29, 2018
October 1, 2018
2 years
October 7, 2018
October 25, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Disease burden
1 year
Study Arms (2)
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
Patients with stroke without structured management
Control subject who have stroke and did not managed according to the SECRET 6 level metrics
Interventions
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
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
Alexandria, 22121, Egypt
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 2 Years
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof of neurology alexandria university
Study Record Dates
First Submitted
October 7, 2018
First Posted
October 29, 2018
Study Start
May 20, 2018
Primary Completion
May 19, 2020
Study Completion
July 30, 2020
Last Updated
October 29, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- once start for 7 years
- Access Criteria
- registred user to Site Data Non registered User to Stat Data