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Trial record 1 of 1 for:    NCT00084292
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Database for Stroke in Infants and Children: the International Pediatric Stroke Study (IPSS)

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ClinicalTrials.gov Identifier: NCT00084292
Recruitment Status : Recruiting
First Posted : June 10, 2004
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Gabrielle deVeber, The Hospital for Sick Children

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 data and imaging core for multi-disciplinary pediatric experts who perform international collaborative research in an effort 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 stroke or are at high risk of having a stroke into the registry. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap. 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.

All information captured in the study is de-identified.

This study does not require any interventions or additional visits for research. Two outcome measures are typically administered during a follow-up clinic visit: the Paediatric Stroke Outcome Measure (PSOM) and the Recovery and Recurrence Questionnaire (RRQ). The PSOM is used during clinic visits by the study PI or co-investigator; the RRQ is a parental questionnaire that can be completed during clinic visits or by telephone interview for those parents who cannot attend the follow up appointment. Both measures assess neurological function in the following 5 domains: sensory, motor, language, cognition and behavior.

Participating investigators will retain ownership of their own (single-site) data. However, by entering data into the IPSS, co-investigators give implicit permission for the IPSS to analyze the collective dataset. These contributing investigators are recognized through authorship.

The activities of the network are creating the opportunity for manuscript writing, grant development and collaboration on clinical challenges in pediatric stroke.


Condition or disease
Cerebrovascular Accident

Detailed Description:

OBJECTIVES: This is the first multi-center, multi-national study of children with stroke. It seeks to build a network of investigators and high-quality disease data to enable population-based studies, natural history studies, and clinical trials to improve the care of children with stroke.

STUDY POPULATION: Infants and children with ischemic stroke (arterial ischemic stroke and cerebral sinovenous thrombosis), or those at high risk (e.g. arteriopathies).

DESIGN: This study includes a data collection component and collaborative process. Our network of over 150 investigators prospectively collect data on neonates or children with a diagnosis of stroke made after January 2003. Data on stroke diagnosis, etiology, treatment and outcomes are collected and entered into a secure web system, REDCap. Neuro-imaging data from the index event and a series of follow-up time points are captured and stored in the SILC-IPSS data repository.

OUTCOME MEASURES: This study will quantify outcome event rates (initial stroke characteristics, recurrent stroke, mortality, neurologic deficits), which can be used in designing future intervention studies and determining sample sizes. Analysis will be primarily descriptive. Participating investigators submit investigator-initiated research proposals or grants with a specific focus, leveraging the clinical and imaging dataset.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: International Pediatric Stroke Study
Study Start Date : January 2003
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from Pediatric Stroke Outcome Measure at 3 months. [ Time Frame: 3 & 12 months post-stroke ]
    The Pediatric Stroke Outcome Measure (PSOM) was developed out of a need for an objective, standardized outcome measures for children with acute, unilateral focal CNS such as cerebral infarction. The goal was to develop an assessment measure that defines clinically and functionally relevant outcome in pediatric stroke. This measure was designed for and tested in children with arterial ischemic stroke or cerebral sinovenous thrombosis.

  2. Recovery and Recurrence Questionnaire [ Time Frame: 3 & 12 months post-stroke ]
    The Recurrence and Recovery Questionnaire (RRQ) was developed by converting the Pediatric Stroke Outcome Measure (PSOM) into a questionnaire for patient/parent telephone interview. The agreement and consistency of the PSOM and RRQ is then assessed, and identified conditions that contributed to differences between the 2 measures. The RRQ has been validated to capture the same 5 sub-domains as the PSOM in the event a patient cannot return to clinic for a follow-up visit and can be used as a measure of recovery post-stroke.


Secondary Outcome Measures :
  1. Investigator-Initiated Research Studies [ Time Frame: As proposed ]
    Participating in the IPSS gives investigators permission to conduct multi-site research studies, in accordance with the Publications Committee policy. Manuscripts published to date can be accessed through IPSS Central (ipss.research@sickkids.ca).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neonates (<28 days) and children (>29 days) with arterial ischemic stroke and cerebral sinovenous thrombosis.
Criteria

Inclusion Criteria

Arterial Ischemic Stroke (AIS):

  • Event diagnosis: Diagnosed after Jan 1, 2003
  • Age: Patient between >36 weeks and 18 years of age Notes: preterm included if stroke onset was in childhood
  • Clinical Criteria: Focal neurological deficit of acute onset lasting greater than 20 minutes
  • Radiological Criteria: CT /MRI showing infarct in location consistent with neurological signs and symptoms Notes: Can include Hypoxic ischemic event with diffuse or bilateral infarction if there is a definite focal, single arterial infarct in a specified vascular territory.

Cerebral Sinovenous Thrombosis (CSVT):

  • Event diagnosis: Diagnosed after January 1, 2003
  • Age: Patient pre-term to 18 years of age Notes: pre-term babies <36 according to IPSS definition, included
  • Clinical Criteria: Any transient neurological dysfunction including headache, seizure, decreased level of consciousness, focal neurological signs consistent with CSVT
  • Radiological Criteria: Thrombosis of cerebral veins or venous sinus seen on MRI, MR venography or CT venography Notes: CT alone if definite is acceptable for older infants and children, but not for neonates under 1 month of age

Cerebral Vascular Conditions (other than CSVT/AIS):

  • Presumed Perinatal Ischemic Strokes: Infants and children whose stroke is presumed to have occurred in the prenatal or perinatal period Notes: These patients have normal development history up until 4-8 months of age, when they present with early hand preference.
  • Arteriopathy without stroke
  • Arteritis, vasculitis, vasculopathy, Moya Moya with no clinical events or TIA
  • Dissections without stroke (can also include those from traumatic brain injury)
  • Watershed infarct with Sickle Cell Disease

Exclusion criteria:

Arterial Ischemic Stroke (AIS)

  • Pre-term not included
  • Cerebral haemorrhage not associated with ischemic infarct
  • HIE with diffuse or bilateral infarction alone

Cerebral Sinovenous Thrombosis (CSVT)

  • Cerebral haemorrhage not associated with ischemic infarct
  • HIE with diffuse or bilateral infarction alone (not associated with one of the above conditions

Cerebral Vascular Conditions (other than CSVT/AIS)

  • Presumed Perinatal AIS if child is premature
  • Any cerebral artery narrowing with TIA alone. IPSS applies the term TIA (transient ischemic attack) to transitory (less than 24 hours) neurological deficit of vascular origin with no visible (new) infarct on neuroimaging
  • Silent infarcts without arteriopathy. If there is an Arteriopathy, can be enrolled on the basis of arteriopathy and "other condition of interest" would be silent infarct.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084292


Contacts
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Contact: IPSS Central 416-813-8535 ipss.research@sickkids.ca

Locations
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Canada, Ontario
Hospital For Sick Children Recruiting
Toronto, Ontario, Canada
Contact: IPSS Central       ipss.research@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Additional Information:

Publications:
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Responsible Party: Gabrielle deVeber, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00084292    
Other Study ID Numbers: 0019920593
04-N-0210
None applied. ( Other Grant/Funding Number: Auxilium Foundation, Canada )
First Posted: June 10, 2004    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Keywords provided by Gabrielle deVeber, The Hospital for Sick Children:
Ischemia
Pediatric
Etiology
Treatment
Outcome
Childhood Stroke
Pediatric Stroke
Ischemic Stroke
Spastic Hemiplegia
Hemiplegic cerebral palsy
Neonatal Stroke
Neuroimaging
Arteriopathy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases