StrokeIMPROVENCT04738071
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
An observational study of Stroke and Patent Foramen Ovale, run by Luciano A. Sposato at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Patent Foramen Ovale, Atrial Fibrillation
- What is being tested?
- PFO closure
- Type of treatment
- Medical device
- How many people
- 3,730 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2019to 13 Nov 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Age <18 years
- Venous stroke
- Stroke mimics
- Patients with incomplete data at 12 months after the index ischemic stroke or TIA.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- PFO closure
- Medical subject headings
- Stroke, Foramen Ovale, Patent, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closureDevice
PFO closure after stroke or transient ischemic attack
| Study group | Role | What they receive |
|---|---|---|
| Sex | Female and male patients Receives: Device: PFO closure | |
| Age >60 years of age | Patients younger or oder than 6o years of age Receives: Device: PFO closure | |
| World region | Patients from different world regions: North America, Europe, Asia, Latin America Receives: Device: PFO closure | |
| Stroke vs. TIA | Index event: stroke vs. TIA Receives: Device: PFO closure | |
| Neurocardiology Teams | Patients assessed by a neurocardiology team Receives: Device: PFO closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent stroke
Recurrent hemorrhagic or ischemic stroke
Measured: Duration of follow-up (minimum of 3 months)
Secondary outcomes (2)
Incident atrial fibrillation
New diagnosis of atrial fibrillation after the index date
Measured: Duration of follow-up (minimum of 3 months)
Proportion of patients undergoing PFO closure
Proportion of patients undergoing PFO closure
Measured: Within 12 months of the index diagnosis of PFO after the stroke or transient ischemic attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start13 Nov 2019
- Primary completion13 Nov 2022
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,730 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Luciano A. Sposato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luciano A. Sposato, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Luciano A Sposato, MD, MBA (PI), Principal investigator, London Health Sciences Centre, Western University (London, ON. Canada)Antonio Arauz, MD (Co-Pi), Principal investigator, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738071
- Sponsor's protocol ID
- R-19-597
- Acronym
- IMPROVE
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request and after the Approval of Western University Ethics Review Board