International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Active, not recruiting

• Conditions: Stroke; Atrial Flutter; Patent Foramen Ovale; Atrial Fibrillation
• Interventions: Device: PFO closure

• Registration Number: NCT04738071
• Lead Sponsor: Lawson Health Research Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Primary Completion: 2022-11-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Study Completion: 2025-11-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3730

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sex	PFO closure	Female and male patients
Stroke vs. TIA	PFO closure	Index event: stroke vs. TIA
Age >60 years of age	PFO closure	Patients younger or oder than 6o years of age
Neurocardiology Teams	PFO closure	Patients assessed by a neurocardiology team
World region	PFO closure	Patients from different world regions: North America, Europe, Asia, Latin America

Primary Outcome Measures

Name	Time	Method
Recurrent stroke	Duration of follow-up (minimum of 3 months)	Recurrent hemorrhagic or ischemic stroke

Secondary Outcome Measures

Name	Time	Method
Incident atrial fibrillation	Duration of follow-up (minimum of 3 months)	New diagnosis of atrial fibrillation after the index date
Proportion of patients undergoing PFO closure	Within 12 months of the index diagnosis of PFO after the stroke or transient ischemic attack	Proportion of patients undergoing PFO closure

Trial Locations

Locations (1)

Heart & Brain Lab, Western University; 🇨🇦 London, Ontario, Canada