International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Study Overview
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Brief Summary
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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.

Official Title
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International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

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

Intervention / Treatment
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* Device: PFO closure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sex<br>Female and male patients | Device: PFO closure<br>* PFO closure after stroke or transient ischemic attack<br>|
| Age >60 years of age<br>Patients younger or oder than 6o years of age | Device: PFO closure<br>* PFO closure after stroke or transient ischemic attack<br>|
| World region<br>Patients from different world regions: North America, Europe, Asia, Latin America | Device: PFO closure<br>* PFO closure after stroke or transient ischemic attack<br>|
| Stroke vs. TIA<br>Index event: stroke vs. TIA | Device: PFO closure<br>* PFO closure after stroke or transient ischemic attack<br>|
| Neurocardiology Teams<br>Patients assessed by a neurocardiology team | Device: PFO closure<br>* PFO closure after stroke or transient ischemic attack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke | Recurrent hemorrhagic or ischemic stroke | Duration of follow-up (minimum of 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident atrial fibrillation | New diagnosis of atrial fibrillation after the index date | Duration of follow-up (minimum of 3 months) | 
| 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 |