Ischemic StrokeNCT04331457
Predictors Of Stroke Outcome In Chidren
An observational study of Ischemic Stroke and Hemorrhagic Shock, run by Assiut University.
Trial summary
Stroke can be defined as an abrupt loss of brain function that is caused by decreased cerebral blood flow. Stroke can occur at all stages of life, but presentation is variable depending on age, involved artery, and underlying risk factors. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Shock
- What is being tested?
- Brain magnetic resonance imaging (MRI) , computed tomography (CT)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Dec 2021
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: infant and children diagnosed as stroke by CT brain and MRI brain
Who may be able to join
- - Infant and Children around age of (1month to 18years old) of both sexes were diagnosed as stroke (hemorrhagic or ischemic) by CT or MRI.
Who cannot join
- - Neonates (less than one month)
- Stroke caused by trauma
- Patient refusal to participate the research
About this study
Official title: Predictors Of Stroke Outcome In Children Admitted To Assiut University Children Hospital
Stroke can be defined as an abrupt loss of brain function that is caused by decreased cerebral blood flow.
Stroke can occur at all stages of life, but presentation is variable depending on age, involved artery, and underlying risk factors.
Read the detailed description
Introduction Stroke can be defined as an abrupt loss of brain function that is caused by decreased cerebral blood flow.
Stroke can occur at all stages of life, but presentation is variable depending on age, involved artery, and underlying risk factors.
Younger children usually present with non specific symptoms such as seizures and altered mental status, especially those younger than 1 year, whereas older children present with focal neurologic deficits such as hemiplegia.(Rosa M et al ., 2016) Types pediatric stroke can be divided into ischemic and hemorrhagic stroke. Ischemic stroke is defined as focal damage to an area of brain tissue within a vascular territory due to loss of blood flow or oxygenation. It differs from diffuse hypoxic-ischemic injury in its mechanisms and distribution. Ischemic stroke, which represents 55% of pediatric strokes, can be subdivided into injuries caused by arterial ischemic stroke (AIS), which is due to loss of arterial flow, or venous infarction, which is due to loss of flow in a draining cerebral vein or venous sinus. Cerebral sinovenous thrombosis (CSVT), which involves obstruction by clot of a major venous sinus draining the brain parenchyma, can lead to infarcted brain parenchyma; Hemorrhagic stroke includes spontaneous hemorrhage within the brain parenchyma (intraparenchymal hemorrhage) and spontaneous (nontraumatic) subarachnoid hemorrhage. (Miya E et al.,2016) Risk factors Risk factors for stroke in children differ from those in adults. Adult risk factors are centered mainly on obstructive atherosclerotic, arteriopathies, cardiovascular disease, and arrhythmias, which are seldom found as risk factors in children. Stroke in children occurs primarily through 2 mechanisms, ischemic and hemorrhagic.
The most common cause of ischemic stroke is thrombotic, which occurs more commonly in children, representing 30% to 60% of cases. Although less common in children, hemorrhagic stroke is mainly caused by arteriovenous malformation.1 Studies such as the International Pediatric Stroke Study (IPSS) have reported systemic risk factors for pediatric stroke including sickle cell disease, cardiac disorders, trauma, and major infections such as meningitis, sepsis, and encephalitis, but in most cases, no systemic disease was found.(Rose M et al ., 2015) \&(Simma B et al., 2013) Outcome of stroke Outcome of arterial ischemic stroke (AIS) in children is considered more favorable than in adults due to the better brain plasticity in children. However, several studies showed that more than half of survivors of childhood AIS have long-term physical disabilities and cognitive impairment. (Studer M et al .,2014) Although stroke etiolog and risk factors were different, stroke severity and clinical outcomes were similar (Bigi S et al .,2011) younger age at stroke is associated with poorer intellectual outcome and a broader spectrum of dysfunctions across multiple neuropsychological domains.(Allman C et al.,2013) Further, children with combined cortical and subcortical lesions have overall poorer cognitive outcome,(Westmacott R et al,.2010) larger lesion size negatively influences cognitive and functional outcome, possibly due to disruption of more neural network connections, adversely affecting functional brain organization.(Long B et al., 2011).
Regarding lesion laterality, controversial reports exist concerning the effect of lesion laterality on neuropsychological outcome. In addition, persistent seizures and persistent NI such as hemiplegia/paresis or visual field deficits also negatively influence neuropsychological and functional outcome. . (Allman C et al.,2013) NeuroImaging Brain magnetic resonance imaging (MRI) as more sensitive than computed tomography (CT) in diagnosis and detection of pediatric stroke. Head CT without contrast is the study of choice for identifying acute hemorrhage but may be normal in the cases of ischemic stroke in the first 12 to 24 hours after the event .( Alberts MJ et al., 2011)\& (Elbers J et al.,2015) Therefore, MRI is a more sensitive modality for stroke including AIS, vascular malformations, and central nervous system inflammatory changes. Non contrast CT used for the detection of brain ischemia is more sensitive after the initial 24 hours.
- Conditions
- Ischemic Stroke, Hemorrhagic Shock
- Being tested
- Brain magnetic resonance imaging (MRI) , computed tomography (CT)
- Keywords
- Seizures, Coma,, Altered mental status, Headache
- Medical subject headings
- Ischemic Stroke, Shock, Hemorrhagic, Seizures, Coma, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain magnetic resonance imaging (MRI) , computed tomography (CT)Radiation
Also called complete blood count , echocardiography
imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Computed tomography(CT) of the brain
To detect the stroke type ;(hemorrhagic or ischemic) , location and severity at admission (at start of the study) and after discharge (6 months after discharge) .
Measured: Baseline to 6 months after discharge
Brain magnetic resonance imaging (MRI)
It is more sensitive than brain CT in diagnosis and detection of pediatric stroke including AIS , vascular malformations , and central nervous system inflammatory changes.
Measured: 1Year
Glasgow coma scale(GCS).
To assess the level of consciousness to evaluate the extent of brain damage;(15_12) mild brain damage,(12_8) moderate brain damage,(<8 )severe brain damage.
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 posted2 Apr 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahlam Abdelbast Mohamad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331457
- Sponsor's protocol ID
- posoicauch
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goeggel Simonetti B, Cavelti A, Arnold M, Bigi S, Regenyi M, Mattle HP, Gralla J, Fluss J, Weber P, Hackenberg A, Steinlin M, Fischer U. Long-term outcome after arterial ischemic stroke in children and young adults. Neurology. 2015 May 12;84(19):1941-7. doi: 10.1212/WNL.0000000000001555. Epub 2015 Apr 10.
PubMed 25862797Studer M, Boltshauser E, Capone Mori A, Datta A, Fluss J, Mercati D, Hackenberg A, Keller E, Maier O, Marcoz JP, Ramelli GP, Poloni C, Schmid R, Schmitt-Mechelke T, Wehrli E, Heinks T, Steinlin M. Factors affecting cognitive outcome in early pediatric stroke. Neurology. 2014 Mar 4;82(9):784-92. doi: 10.1212/WNL.0000000000000162. Epub 2014 Jan 31.
PubMed 24489131McKinney SM, Magruder JT, Abramo TJ. An Update on Pediatric Stroke Protocol. Pediatr Emerg Care. 2018 Nov;34(11):810-815. doi: 10.1097/PEC.0000000000001653.
PubMed 30395072Chiang KL, Cheng CY. Epidemiology, risk factors and characteristics of pediatric stroke: a nationwide population-based study. QJM. 2018 Jul 1;111(7):445-454. doi: 10.1093/qjmed/hcy066.
PubMed 29648667
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors Of Stroke Outcome In Children Admitted To Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04331457
- Acronym / sponsor ID
- posoicauch
- Conditions
- Ischemic Stroke, Hemorrhagic Shock
- Keywords
- Seizures, Coma,, Altered mental status, Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 2 Apr 2020 (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.
Stroke can be defined as an abrupt loss of brain function that is caused by decreased cerebral blood flow.
Stroke can occur at all stages of life, but presentation is variable depending on age, involved artery, and underlying risk factors.
Detailed description
Introduction Stroke can be defined as an abrupt loss of brain function that is caused by decreased cerebral blood flow.
Stroke can occur at all stages of life, but presentation is variable depending on age, involved artery, and underlying risk factors.
Younger children usually present with non specific symptoms such as seizures and altered mental status, especially those younger than 1 year, whereas older children present with focal neurologic deficits such as hemiplegia.(Rosa M et al ., 2016) Types pediatric stroke can be divided into ischemic and hemorrhagic stroke. Ischemic stroke is defined as focal damage to an area of brain tissue within a vascular territory due to loss of blood flow or oxygenation. It differs from diffuse hypoxic-ischemic injury in its mechanisms and distribution. Ischemic stroke, which represents 55% of pediatric strokes, can be subdivided into injuries caused by arterial ischemic stroke (AIS), which is due to loss of arterial flow, or venous infarction, which is due to loss of flow in a draining cerebral vein or venous sinus. Cerebral sinovenous thrombosis (CSVT), which involves obstruction by clot of a major venous sinus draining the brain parenchyma, can lead to infarcted brain parenchyma; Hemorrhagic stroke includes spontaneous hemorrhage within the brain parenchyma (intraparenchymal hemorrhage) and spontaneous (nontraumatic) subarachnoid hemorrhage. (Miya E et al.,2016) Risk factors Risk factors for stroke in children differ from those in adults. Adult risk factors are centered mainly on obstructive atherosclerotic, arteriopathies, cardiovascular disease, and arrhythmias, which are seldom found as risk factors in children. Stroke in children occurs primarily through 2 mechanisms, ischemic and hemorrhagic.
The most common cause of ischemic stroke is thrombotic, which occurs more commonly in children, representing 30% to 60% of cases. Although less common in children, hemorrhagic stroke is mainly caused by arteriovenous malformation.1 Studies such as the International Pediatric Stroke Study (IPSS) have reported systemic risk factors for pediatric stroke including sickle cell disease, cardiac disorders, trauma, and major infections such as meningitis, sepsis, and encephalitis, but in most cases, no systemic disease was found.(Rose M et al ., 2015) \&(Simma B et al., 2013) Outcome of stroke Outcome of arterial ischemic stroke (AIS) in children is considered more favorable than in adults due to the better brain plasticity in children. However, several studies showed that more than half of survivors of childhood AIS have long-term physical disabilities and cognitive impairment. (Studer M et al .,2014) Although stroke etiolog and risk factors were different, stroke severity and clinical outcomes were similar (Bigi S et al .,2011) younger age at stroke is associated with poorer intellectual outcome and a broader spectrum of dysfunctions across multiple neuropsychological domains.(Allman C et al.,2013) Further, children with combined cortical and subcortical lesions have overall poorer cognitive outcome,(Westmacott R et al,.2010) larger lesion size negatively influences cognitive and functional outcome, possibly due to disruption of more neural network connections, adversely affecting functional brain organization.(Long B et al., 2011).
Regarding lesion laterality, controversial reports exist concerning the effect of lesion laterality on neuropsychological outcome. In addition, persistent seizures and persistent NI such as hemiplegia/paresis or visual field deficits also negatively influence neuropsychological and functional outcome. . (Allman C et al.,2013) NeuroImaging Brain magnetic resonance imaging (MRI) as more sensitive than computed tomography (CT) in diagnosis and detection of pediatric stroke. Head CT without contrast is the study of choice for identifying acute hemorrhage but may be normal in the cases of ischemic stroke in the first 12 to 24 hours after the event .( Alberts MJ et al., 2011)\& (Elbers J et al.,2015) Therefore, MRI is a more sensitive modality for stroke including AIS, vascular malformations, and central nervous system inflammatory changes. Non contrast CT used for the detection of brain ischemia is more sensitive after the initial 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- infant and children diagnosed as stroke by CT brain and MRI brain
Key inclusion criteria (1 listed)
- - Infant and Children around age of (1month to 18years old) of both sexes were diagnosed as stroke (hemorrhagic or ischemic) by CT or MRI.
Key exclusion criteria (3 listed)
- - Neonates (less than one month)
- Stroke caused by trauma
- Patient refusal to participate the research
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 |
|---|---|---|
| Brain magnetic resonance imaging (MRI) , computed tomography (CT)Also: complete blood count , echocardiographyimaging | Radiation | – |
Primary outcome
Computed tomography(CT) of the brain
Time frame: Baseline to 6 months after discharge
To detect the stroke type ;(hemorrhagic or ischemic) , location and severity at admission (at start of the study) and after discharge (6 months after discharge) .
Brain magnetic resonance imaging (MRI)
Time frame: 1Year
It is more sensitive than brain CT in diagnosis and detection of pediatric stroke including AIS , vascular malformations , and central nervous system inflammatory changes.
Glasgow coma scale(GCS).
Time frame: 1 year
To assess the level of consciousness to evaluate the extent of brain damage;(15_12) mild brain damage,(12_8) moderate brain damage,(<8 )severe brain damage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 25862797Goeggel Simonetti B, Cavelti A, Arnold M, Bigi S, Regenyi M, Mattle HP, Gralla J, Fluss J, Weber P, Hackenberg A, Steinlin M, Fischer U. Long-term outcome after arterial ischemic stroke in children and young adults. Neurology. 2015 May 12;84(19):1941-7. doi: 10.1212/WNL.0000000000001555. Epub 2015 Apr 10.
- Background: PubMed 24489131Studer M, Boltshauser E, Capone Mori A, Datta A, Fluss J, Mercati D, Hackenberg A, Keller E, Maier O, Marcoz JP, Ramelli GP, Poloni C, Schmid R, Schmitt-Mechelke T, Wehrli E, Heinks T, Steinlin M. Factors affecting cognitive outcome in early pediatric stroke. Neurology. 2014 Mar 4;82(9):784-92. doi: 10.1212/WNL.0000000000000162. Epub 2014 Jan 31.
- Background: PubMed 30395072McKinney SM, Magruder JT, Abramo TJ. An Update on Pediatric Stroke Protocol. Pediatr Emerg Care. 2018 Nov;34(11):810-815. doi: 10.1097/PEC.0000000000001653.
- Background: PubMed 29648667Chiang KL, Cheng CY. Epidemiology, risk factors and characteristics of pediatric stroke: a nationwide population-based study. QJM. 2018 Jul 1;111(7):445-454. doi: 10.1093/qjmed/hcy066.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Hemorrhagic Shock, run by Assiut University.
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 1 inclusion and 3 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed tomography(CT) of the brain (time frame: Baseline to 6 months after discharge). 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?
On the ClinicalTrials.gov record for NCT04331457, which also lists 4 linked publications.
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 2 Apr 2020.