International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

NCT ID: NCT04738071

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3730 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2025-11-13

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.

Conditions

Stroke; Patent Foramen Ovale; Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Sex

Female and male patients

PFO closure

Intervention Type: DEVICE

PFO closure after stroke or transient ischemic attack

Age >60 years of age

Patients younger or oder than 6o years of age

PFO closure

Intervention Type: DEVICE

PFO closure after stroke or transient ischemic attack

World region

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

PFO closure

Intervention Type: DEVICE

PFO closure after stroke or transient ischemic attack

Stroke vs. TIA

Index event: stroke vs. TIA

PFO closure

Intervention Type: DEVICE

PFO closure after stroke or transient ischemic attack

Neurocardiology Teams

Patients assessed by a neurocardiology team

PFO closure

Intervention Type: DEVICE

PFO closure after stroke or transient ischemic attack

Interventions

PFO closure

PFO closure after stroke or transient ischemic attack

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Age <18 years
• Venous stroke
• Stroke mimics
• Patients with incomplete data at 12 months after the index ischemic stroke or TIA.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciano A Sposato, MD, MBA (PI)

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Western University (London, ON. Canada)

Antonio Arauz, MD (Co-Pi)

Role: PRINCIPAL_INVESTIGATOR

National Institute of Neurology and Neurosurgery Manuel Velasco Suárez

Locations

Heart & Brain Lab, Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

R-19-597

Identifier Type: -

Identifier Source: org_study_id