Database for Stroke in Infants and Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Hospital for Sick Children
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00084292
First received: June 9, 2004
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

This multi-center collaborative study will establish a database of information about stroke in infants and children.

Children 0 to 18 years of age who: 1) have had an ischemic stroke after January 1, 2003; 2) have a history of spastic hemiplegic or quadriplegic cerebral palsy and X-ray evidence of ischemic stroke after January 1, 2003; or 3) are diagnosed with ischemic stroke defined by a new focal neurologic deficit lasting 24 hours or more and presumed due to vessel obstruction or narrowing may be eligible to participate this study.

Participating children have their medical and research records reviewed for information about their stroke. The information is gathered and entered into an internet database. Parents may be interviewed to obtain additional information, if needed. No identifying information is entered into the database, so that the child's participation remains anonymous. The resulting registry may allow physicians to better diagnose, treat, and prevent stroke in children, and will help in developing and conducting new clinical trials to study this disease.


Condition
Cerebrovascular Accident

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: International Pediatric Stroke Study

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Pediatric Stroke outcome Measure [ Time Frame: 3 and 12 months post-stroke ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • discharge destination [ Time Frame: at discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 12000
Study Start Date: June 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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 baseline disease data, to enable childhood stroke clinical trials to be developed.

STUDY POPULATION: Infants and children with ischemic stroke (arterial ischemic stroke and sinovenous thrombosis).

DESIGN: This study is a prospective cohort study conducted consecutively at over 70 centers worldwide. This cohort will be used to develop and apply standardized protocols in a study setting for the diagnosis, etiological investigation, treatment, and outcome assessment of infants and children with ischemic stroke (arterial ischemic stroke and sinovenous thrombosis). Children, with diagnosis of stroke made after January 2003, will be prospectively enrolled into a web-based data entry system.

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. Some predictor testing for outcomes within strata may be utilized for web-based data.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

neonates and children with arterial ischemic stroke and cerebral sinovenous thrombosis

Criteria
  • INCLUSION CRITERIA:

Children, 0 to 18 years of age, with an event of ischemic stroke after January 1, 2003;

Children, 0 to 18 years of age, with a history of spastic hemiplegic or quadriplegic cerebral palsy with radiographic evidence of ischemic stroke occurring after January 1, 2003;

A diagnosis of ischemic stroke (arterial ischemic stroke or sinovenous thrombosis) as defined by a new focal neurologic deficit lasting greater than or equal to 24 hours and presumably due to a vascular process and confirmed by brain imaging, either computed tomography (CT), magnetic resonance (MR), or Doppler ultrasonography;

Informed consent of the parent; and

Informed assent of the child, when available.

EXCLUSION CRITERIA:

Preterm children (less than 36 weeks gestation);

Children greater than 18 years of age;

Children with an event of ischemic stroke prior to January 1, 2003.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084292

Contacts
Contact: IPSS Co-ordinator ipss.research@sickkids.ca

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

Publications:
Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00084292     History of Changes
Other Study ID Numbers: 0019920593, 04-N-0210
Study First Received: June 9, 2004
Last Updated: May 28, 2013
Health Authority: Canada: Research Ethics Board
United States: Federal Government

Keywords provided by The Hospital for Sick Children:
Ischemia
Pediatric
Etiology
Treatment
Outcome
Childhood Stroke
Pediatric Stroke
Ischemic Stroke
Spastic Hemiplegia
Hemiplegic cerebral palsy

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014