Clinical trial NCT04738071: International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Official title: International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Patent Foramen Ovale
Atrial Fibrillation
Atrial Flutter
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 3730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility 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.

Primary outcomes:
measure: Recurrent stroke
timeFrame: Duration of follow-up (minimum of 3 months)
Secondary outcomes:
measure: Incident atrial fibrillation
timeFrame: Duration of follow-up (minimum of 3 months)
measure: Proportion of patients undergoing PFO closure
timeFrame: Within 12 months of the index diagnosis of PFO after the stroke or transient ischemic attack
Other outcomes:
measure: Recurrent stroke or death
timeFrame: Duration of follow-up (minimum of 3 months)
measure: Recurrent stroke or myocardial infarction
timeFrame: Duration of follow-up (minimum of 3 months)
Locations:
city: London
country: Canada
facility: Heart & Brain Lab, Western University
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Western University (London, ON. Canada)
name: Luciano A Sposato, MD, MBA (PI)
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
name: Antonio Arauz, MD (Co-Pi)
role: PRINCIPAL_INVESTIGATOR
References: