Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084292
Status:
RECRUITING
Last Update Posted:
2023-04-20
First Post:
2004-06-09
Brief Title:
Database for Stroke in Infants and Children the International Pediatric Stroke Study
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
International Pediatric Stroke Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPSS
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 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
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
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 dataset 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 hemorrhagic stroke or those at high risk eg arteriopathies like moyamoya
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
STUDY POPULATION Infants and children with ischemic stroke arterial ischemic stroke and cerebral sinovenous thrombosis hemorrhagic stroke or those at high risk eg arteriopathies like moyamoya
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0210 | REGISTRY | None | None |
| 1000070460 | REGISTRY | The International Pediatric Stroke Study | None |