Stroke, CardiovascularSECRETNCT03723382
Stroke in Egyptian Clinical REgisTry
An observational study of Stroke, Cardiovascular and Stroke, Acute, run by Society of Minimally Invasive Neurological Therapeutic Procedures at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Cardiovascular, Stroke, Acute, Stroke Hemorrhagic
- What is being tested?
- SECRET structured 5 bundles of standard healthcare services
- Type of treatment
- Injection or infusion
- How many people
- 50,000 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2018to 30 Jul 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
Alexandria, 22121
ossama Mansour, MD,PhD,FNR, 01223926932, yassinossama@yahoo.com
Ashraf Abdo, MD,PhD,FNR
About this study
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
Read the 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
- 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.
- 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.
- 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
- Stroke, Cardiovascular, Stroke, Acute, Stroke Hemorrhagic, Stroke Spinal Cord, Stroke, Complication
- Being tested
- SECRET structured 5 bundles of standard healthcare services
- Medical subject headings
- Myocardial Infarction, Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SECRET structured 5 bundles of standard healthcare servicesOther
Also called Iv-Thrombolysis, Endovascular treatment, Rehabilitation , mobilization , bulbar care, secondary prevention, Stroke unit calibration
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: SECRET structured 5 bundles of standard healthcare services | |
| Patients with stroke without structured management | Control subject who have stroke and did not managed according to the SECRET 6 level metrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days post discharge from hospital
Modified Rankin Scale at Discharge
Patients grouped by Modified Rankin Scale at discharge
Measured: 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.
Measured: 30 days post discharge from hospital
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start20 May 2018
- Primary completion19 May 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Society of Minimally Invasive Neurological Therapeutic Procedures
- Sponsor type
- Research network
- Collaborators
- Egyptian Stroke Society, Egyptian Society of Neurological Surgeons, Egyptian Radiology Society, Middle East North Africa Stroke and Interventional Neurotherapies Organization
- Responsible party
- Principal investigator, Prof. Ossama Mansour, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723382
- Sponsor's protocol ID
- ESS015000
- Acronym
- SECRET
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke in Egyptian Clinical REgisTry
- ClinicalTrials.gov ID
- NCT03723382
- Acronym / sponsor ID
- SECRET / ESS015000
- Conditions
- Stroke, Cardiovascular, Stroke, Acute, Stroke Hemorrhagic, Stroke Spinal Cord, Stroke, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Society of Minimally Invasive Neurological Therapeutic ProceduresResearch network
- Collaborators
- Egyptian Stroke Society, Egyptian Society of Neurological Surgeons, Egyptian Radiology Society, Middle East North Africa Stroke and Interventional Neurotherapies Organization
- Study start
- 20 May 2018 (actual)
- Primary completion
- 19 May 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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.
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke with structured management | – | Other: SECRET structured 5 bundles of standard healthcare servicesPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SECRET structured 5 bundles of standard healthcare servicesAlso: Iv-Thrombolysis, Endovascular treatment, Rehabilitation , mobilization , bulbar care, secondary prevention, Stroke unit calibrationTHE 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 | Patients with stroke with structured management |
Primary outcome
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)
Modified Rankin Scale at Discharge
Time frame: 90 days post discharge from hospital
Patients grouped by Modified Rankin Scale at discharge
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.
1 secondary outcome
Disease burden
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- registry websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
Alexandria, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Cardiovascular and Stroke, Acute, run by Society of Minimally Invasive Neurological Therapeutic Procedures at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The National Institutes of Health Stroke Scale (NIHSS) reported (time frame: 30 days post discharge from hospital). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.