International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

NCT04738071 | Active Not Recruiting

• 1 other identifier: R-19-597
• Study Type: observational
• Target: 3,730
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recurrent stroke

  Recurrent hemorrhagic or ischemic stroke

  Duration of follow-up (minimum of 3 months)

Secondary Outcomes (2)

• Incident atrial fibrillation

  Duration of follow-up (minimum of 3 months)

• Proportion of patients undergoing PFO closure

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

Other Outcomes (2)

• Recurrent stroke or death

  Duration of follow-up (minimum of 3 months)

• Recurrent stroke or myocardial infarction

  Duration of follow-up (minimum of 3 months)

Study Arms (5)

Sex

Female and male patients

Device: PFO closure

Age >60 years of age

Patients younger or oder than 6o years of age

Device: PFO closure

World region

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

Device: PFO closure

Stroke vs. TIA

Index event: stroke vs. TIA

Device: PFO closure

Neurocardiology Teams

Patients assessed by a neurocardiology team

Device: PFO closure

Interventions

PFO closure DEVICE

PFO closure after stroke or transient ischemic attack

Age >60 years of age; Neurocardiology Teams; Sex; Stroke vs. TIA; World region

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The IMPROVE registry aims to include patients from Asia, Europe, Oceania, North America and Latin America. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists, since a confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment.

You may qualify if:

• Age ≥18 years
• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano A Sposato, MD, MBA (PI)

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

  PRINCIPAL INVESTIGATOR

• Antonio Arauz, MD (Co-Pi)

  National Institute of Neurology and Neurosurgery Manuel Velasco Suárez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: November 13, 2019
• Primary Completion: November 13, 2022
• Study Completion: November 13, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CA (1)