International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Lawson Health Research Institute

Status: Active, not recruiting

Conditions: Atrial Flutter; Atrial Fibrillation; Stroke; Patent Foramen Ovale

Treatments: Device: PFO closure

Study type: Observational

Funder types: Other

Identifiers

NCT04738071

R-19-597

Details and patient eligibility

About

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.

Enrollment: 3,730 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

3,730 participants in 5 patient groups

Sex

Description:

Female and male patients

Treatment:

Device: PFO closure

Age >60 years of age

Description:

Patients younger or oder than 6o years of age

Treatment:

Device: PFO closure

World region

Description:

Patients from different world regions: North America, Europe, Asia, Latin America

Treatment:

Device: PFO closure

Stroke vs. TIA

Description:

Index event: stroke vs. TIA

Treatment:

Device: PFO closure

Neurocardiology Teams

Description:

Patients assessed by a neurocardiology team

Treatment:

Device: PFO closure