Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT00084292

Conditions

Cerebrovascular Accident

Focal Infarct

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The International Pediatric Stroke Study (IPSS) was established in 2003 as a multi-center, multi-national clinical research registry. Over the years, it has grown to become a highly successful study vehicle for pediatric stroke research across over 100 institutions worldwide. Today, The IPSS continues to serve as the global clinical data and imaging core for multi-disciplinary pediatric experts who perform international collaborative research to better understand, prevent, and improve outcomes in pediatric stroke. The robust dataset and cohesive network enable high caliber and ground-breaking research in the field.

Participating sites enroll neonates or children who have had an ischemic or hemorrhagic stroke, or may be at high risk of having a stroke. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap, which is hosted at SickKids in Toronto Canada. The IPSS also provides an attractive imaging platform (through the Stroke Imaging Lab for Children, SILC, housed at SickKids) for sites to share clinically acquired brain images that will complement the clinical dataset. The clinical and imaging datasets will improve our understanding of the processes underlying plasticity and recovery in childhood stroke.

Conditions

Cerebrovascular Accident

Focal Infarct

Study ID

NCT00084292

Start date

Jan, 2003

Status verified date

May, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

This registry will include all children from birth to 18 years of age who are diagnosed with stroke or a condition/disease (as defined below) that put them at high risk of stroke after Jan 1,2003 at one of the IPSS participating sites.

This registry will include children diagnosed with below stroke types:

  • Arterial Ischemic Stroke (AIS),
  • Cerebral Sinovenous Thrombosis (CSVT),
  • AIS and CSVT
  • Presume Preinatal Ischemic Stroke (PPIS)
  • Children diagnosed with hemorrhagic stroke

Children at high risk of stroke include:

  • Those diagnosed with arteriopathy, arteritis/vasculitis, moyamoya, dissection, sickle cell related infarcts).
  • Brain arteriovenous malformations

Exclusion Criteria:

  • Premature children diagnosed with AIS.
  • Premature children diagnosed with PPIS
  • Children diagnosed with TIA (Transient Ischemic Attack)
  • Brain hemorrhage secondary to trauma
  • Refusal to provide consent for participation

Study Design

Enrollment

12000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change from Pediatric Stroke Outcome Measure at 3 months. [ Time Frame: 3-12 months post-stroke ]
  • Recovery and Recurrence Questionnaire [ Time Frame: 3-12 months post-stroke ]
  • King's Outcome Scale for Childhood Head Injury (KOSCHI) [ Time Frame: 3-12 months post-stroke ]
  • modified Rankin Scale (mRS) [ Time Frame: 3-12 months post-stroke ]

Central Contacts and Locations

Central contacts

Locations

Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 15, 2025

Last verified

May, 2025

Keywords

  • Ischemia
  • Pediatric
  • Etiology
  • Treatment
  • Outcome
  • Childhood Stroke
  • Pediatric Stroke
  • Ischemic Stroke
  • Spastic Hemiplegia
  • Hemiplegic cerebral palsy
  • Neonatal Stroke
  • Neuroimaging
  • Arteriopathy
  • Hemorrhagic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-05-15.