ClinicalTrials.gg
Status unknownNCT03617159Updated Aug 7, 2018

Role of Advanced Magnetic Resonance Imaging in Assessment of Pediatric Cerebral Stroke

An observational study in Pediatric Cerebral Stroke and Brain Infarction/Diagnosis, sponsored by Assiut University. Status unknown. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
68
Ages
5 Years to 15 Years
Sex
All
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Study summary

Stroke can be ischemic, hemorrhagic, or both. Early recognition and treatment of pediatric stroke are critical in optimizing long-term functional outcomes, reducing morbidity and mortality, and preventing recurrent stroke. Neuroimaging plays a vital role in achieving this goal. Neuroimaging is usually the first step in diagnosis, helping discriminate between ischemic/hemorrhagic strokes and also in the identification of underlying potential causes. Multiparametric magnetic resonance imaging (MRI) plays a crucial role in assessing pediatric cerebral stroke including diffusion-weighted imaging (DWI), susceptibility weighted imaging (SWI) and magnetic resonance angiography (MRA).

Read the detailed description

Stroke is a neurological injury caused by the occlusion or rupture of cerebral blood vessels. Stroke can be ischemic, hemorrhagic, or both. Ischemic stroke is more frequently caused by arterial occlusion, but it may also be caused by venous occlusion of cerebral veins or sinuses. Hemorrhagic stroke is the result of bleeding from a ruptured cerebral artery or from bleeding into the site of an acute ischemic stroke. Stroke is relatively rare in children but can lead to significant morbidity and mortality. Understanding that children with strokes present differently than adults and often present with unique risk factors will optimize outcomes in children. Early recognition and treatment of pediatric stroke are critical in optimizing long-term functional outcomes, reducing morbidity and mortality, and preventing recurrent stroke. Neuroimaging plays a vital role in achieving this goal. Neuroimaging is usually the first step in diagnosis, helping discriminate between ischemic/hemorrhagic strokes and also in the identification of underlying potential causes MRI is a more sensitive test for early detection of an infarction. Magnetic resonance arteriography (MRA) and magnetic resonance venography (MRV) should also be carried out to confirm vessel patency and define the vascular anatomy. MRA will yield further information about blood flow, and MRV will more reliably identify cerebral venous sinus thrombosis. MRI has a high sensitivity and specificity in the first hours after symptom onset with the potential to both characterize the ischemic pathology and to differentiate ischemic from hemorrhagic lesions at least as accurately as computed tomography (CT). Most common imaging protocol used for acute ischemic stroke is an emergent/urgent stroke protocol MRI with MRA. This usually takes approximately 13 min for the MRI sequences and 19 min with MRA.

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Conditions studied

  • Pediatric Cerebral Stroke
  • Brain Infarction/Diagnosis

Keywords

  • magnetic resonance imaging
  • diffusion weighted imaging
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In context

Brain Infarction

93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.

This study's planned enrollment of 68 is below the median of 477 across 23 observational studies indexed under Brain Infarction.

Browse Brain Infarction studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the pediatric neurological intensive care unit with cerebral stroke

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with acute pathological changes in the central nervous system CNS within 7 days admitted from outpatient, emergency room, or inpatient department
  • Confirmed diagnosis of acute stroke by clinical testings performed by a neurologist
  • Signed from the patient

Exclusion criteria

Exclusion Criteria:

  • Any person with a pacemaker, metal implant, claustrophobia, or any other for MR examination
  • Any person with epilepsy, brain tumor.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
68 participants (estimated)
Patient registry
No

Interventions

  • DeviceMagnetic Resonance Imaging

    Diagnostic Modality

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What researchers measure

Primary outcomes

  1. To compare the diagnostic accuracy of advanced MRI sequences versus the conventional sequences in early pediatric cerebral stroke.

    To compare the diagnostic accuracy of advanced MRI sequences including diffusion-weighted imaging (DWI and susceptibility weighted imaging (SWI) with the conventional MRI sequences including T1 weighted imaging, T2 weighted imaging and fluid attenuating inversion recovery (FLAIR) in assessing pediatric cerebral stroke in assessing early infarction by DWI and presence of blood signal by SWI and comparing these findings with the MR conventional sequences.

    Time frame: Wiithin the first day of stroke

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Husson B, Rodesch G, Lasjaunias P, Tardieu M, Sebire G. Magnetic resonance angiography in childhood arterial brain infarcts: a comparative study with contrast angiography. Stroke. 2002 May;33(5):1280-5. doi: 10.1161/01.str.0000014504.18199.0d. PubMed 11988604 ↗
  • Husson B, Lasjaunias P. Radiological approach to disorders of arterial brain vessels associated with childhood arterial stroke-a comparison between MRA and contrast angiography. Pediatr Radiol. 2004 Jan;34(1):10-5. doi: 10.1007/s00247-003-1109-0. Epub 2003 Dec 10. PubMed 14669061 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2018; primary completion for Sep 2021, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2018
First posted
Aug 6, 2018
StartEst.
Oct 2018
Primary completionEst.
Sep 2021
CompletionEst.
Nov 2021
Last update
Aug 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03617159
Lead sponsor
Assiut University
Responsible party
Mohammad Farghali Ali (Principal investigator, Assiut University) — Principal investigator
First posted
Aug 6, 2018
Start date
Oct 2018 (estimated)
Primary completion
Sep 2021 (estimated)
Completion
Nov 2021 (estimated)
Last update
Aug 7, 2018

Study contacts

Mohammad Farghali, MD
Contact
radiologydr2017@gmail.com
+201090122141

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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