Status:
ACTIVE_NOT_RECRUITING
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Stroke
Patent Foramen Ovale
Eligibility:
All Genders
18+ years
Brief Summary
Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA (all of the following criteria should be fulfilled)
- Age ≥18 years
- Ischemic stroke or TIA within 5 years and 1 year before inclusion in the registry. Patients with cerebrovascular events occurred within one year before the inclusion in the registry should be part of the prospective cohort.
- Ischemic stroke is defined as:
- focal neurological deficit of central origin lasting ≥24 hours -except for death within 24hrs- with or without imaging confirmation of cerebral infarction; or
- focal neurological deficit of central origin lasting \<24 hours with corresponding imaging evidence of cerebral infarction; or
- focal neurological deficit of central origin lasting \<24 hours in patients receiving IV thrombolysis or endovascular thrombectomy with or without imaging confirmation of cerebral infarction; or
- non-focal encephalopathy lasting more than 24 hours -except for death within 24hrs- with imaging evidence of cerebral infarction; or
- acute and permanent retinal ischemia of arterial origin.
- TIA is defined as:
- focal neurological deficit of central origin lasting \<24 hours without corresponding imaging evidence of cerebral infarction in patients not receiving IV thrombolysis or endovascular thrombectomy.
- Confirmed patent foramen ovale.
- EXCLUSION CRITERIA:
- Exclusion Criteria
- Age \<18 years
- Venous stroke
- Stroke mimics
- Patients with incomplete data at 12 months after the index ischemic stroke or TIA.
Exclusion
Key Trial Info
Start Date :
November 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2025
Estimated Enrollment :
3730 Patients enrolled
Trial Details
Trial ID
NCT04738071
Start Date
November 13 2019
End Date
November 13 2025
Last Update
March 13 2024
Active Locations (1)
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1
Heart & Brain Lab, Western University
London, Ontario, Canada, N6A 5A5