International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Stroke Clinical Trial

— IMPROVE  

Official title:

International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04738071
• Other study ID #: R-19-597
• Status: Active, not recruiting
• Start date: November 13, 2019
• Est. completion date: November 13, 2025

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally. The IMPROVE (International Multicenter Patent foRamen OVale & strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3730
• Est. completion date: November 13, 2025
• Est. primary completion date: November 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Foramen Ovale, Patent
• Patent Foramen Ovale
• Stroke

Intervention

Device:
• PFO closure
PFO closure after stroke or transient ischemic attack

Locations

Country	Name	City	State
Canada	Heart & Brain Lab, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrent stroke or death	Recurrent hemorrhagic or ischemic stroke, or death	Duration of follow-up (minimum of 3 months)
Other	Recurrent stroke or myocardial infarction	Recurrent hemorrhagic or ischemic stroke, or myocardial infarction	Duration of follow-up (minimum of 3 months)
Primary	Recurrent stroke	Recurrent hemorrhagic or ischemic stroke	Duration of follow-up (minimum of 3 months)
Secondary	Incident atrial fibrillation	New diagnosis of atrial fibrillation after the index date	Duration of follow-up (minimum of 3 months)
Secondary	Proportion of patients undergoing PFO closure	Proportion of patients undergoing PFO closure	Within 12 months of the index diagnosis of PFO after the stroke or transient ischemic attack