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NCT Number: NCT04738071

International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Nervous System Diseases Patent Foramen Ovale Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PFO closure

Device

PFO closure after stroke or transient ischemic attack

Primary outcomes

  1. Recurrent stroke

    Time frame: Duration of follow-up (minimum of 3 months)

    Recurrent hemorrhagic or ischemic stroke

Secondary outcomes

  1. Incident atrial fibrillation

    Time frame: Duration of follow-up (minimum of 3 months)

    New diagnosis of atrial fibrillation after the index date

  2. Proportion of patients undergoing PFO closure

    Time frame: Within 12 months of the index diagnosis of PFO after the stroke or transient ischemic attack

    Proportion of patients undergoing PFO closure

Other outcomes

  1. Recurrent stroke or death

    Time frame: Duration of follow-up (minimum of 3 months)

    Recurrent hemorrhagic or ischemic stroke, or death

  2. Recurrent stroke or myocardial infarction

    Time frame: Duration of follow-up (minimum of 3 months)

    Recurrent hemorrhagic or ischemic stroke, or myocardial infarction

Sponsors and collaborators

Lead sponsor

Luciano A. Sposato

Other

Registry information

Acronym: IMPROVE

Important dates

Study start
2019
Primary completion
2022
Study completion
2026
First posted
Feb 4, 2021
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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