NCT03617159

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

July 25, 2018

Last Update Submit

August 5, 2018

Conditions

Keywords

magnetic resonance imagingdiffusion weighted imaging

Outcome Measures

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.

    Wiithin the first day of stroke

Interventions

Diagnostic Modality

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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 informed consent from the patient

You may not qualify if:

  • Any person with a pacemaker, metal implant, claustrophobia, or any other contraindication for MR examination
  • Any person with epilepsy, brain tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 11988604BACKGROUND
  • 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.

    PMID: 14669061BACKGROUND

MeSH Terms

Conditions

Brain InfarctionDisease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mohammad Farghali, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 6, 2018

Study Start

October 1, 2018

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

August 7, 2018

Record last verified: 2018-08