- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617159
Role of Advanced Magnetic Resonance Imaging in Assessment of Pediatric Cerebral Stroke
August 5, 2018 updated by: Mohammad Farghali Ali, Assiut University
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).
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the pediatric neurological intensive care unit with cerebral stroke
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the diagnostic accuracy of advanced MRI sequences versus the conventional sequences in early pediatric cerebral stroke.
Time Frame: Wiithin the first day of 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2018
Primary Completion (ANTICIPATED)
September 1, 2021
Study Completion (ANTICIPATED)
November 1, 2021
Study Registration Dates
First Submitted
July 25, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (ACTUAL)
August 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 5, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRI in Pediatric Brain stroke
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.