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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03617159
Other study ID # MRI in Pediatric Brain stroke
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2018
Est. completion date November 2021

Study information

Verified date August 2018
Source Assiut University
Contact Mohammad Farghali, MD
Phone +201090122141
Email radiologydr2017@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date November 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 15 Years
Eligibility 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 informed consent from the patient

Exclusion Criteria:

- Any person with a pacemaker, metal implant, claustrophobia, or any other contraindication for MR examination

- Any person with epilepsy, brain tumor.

Study Design


Intervention

Device:
Magnetic Resonance Imaging
Diagnostic Modality

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. Epub 2003 Dec 10. — View Citation

Husson B, Rodesch G, Lasjaunias P, Tardieu M, Sébire G. Magnetic resonance angiography in childhood arterial brain infarcts: a comparative study with contrast angiography. Stroke. 2002 May;33(5):1280-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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