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CompletedNCT04043559Updated Dec 3, 2025

Cortical Cerebellar Infarctions Associated With Patent Foramen Ovale in Young Stroke Patients

An observational study in Brain Infarction, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years to 60 Years
Sex
All
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Study summary

The investigator retrospectively analyzed consecutive young (\<60 years) cryptogenic stroke patients with Patient Foramen Ovale (PFO) recruited between January 2016 and May 2019 in our center, and compared these patients with sex- and age-matched controls with cryptogenic stroke without PFO. Analyzed baseline characteristics: sex, age, cardiovascular risk factors, history of stroke, and cortical/subcortical localization, arterial territory, number of lesions, and lesion size of the acute symptomatic infarction, together with the ROPE score. The presence and the number of acute and chronic SCCI lesions were assessed.

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Conditions studied

  • Brain Infarction

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In context

Brain Infarction

93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.

This study's enrollment of 50 is below the median of 477 across 23 observational studies indexed under Brain Infarction.

Browse Brain Infarction studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive young (\<60 years) cryptogenic stroke patients with PFO recruited between January 2016 and May 2019 in our center, and compared these patients with sex- and age-matched controls with cryptogenic stroke without PFO.

Eligibility criteria

Inclusion Criteria:

  • patients : young (\<60 years) adult patients,
  • Patient recruited and registered in our stroke database between January 2016 and May 2016 of our center (Nîmes University Hospital, France),
  • Patients presenting with an acute symptomatic infarction (confirmed by diffusion-weighted MRI) of unknown origin
  • Controls : age-matched controls with cryptogenic stroke without PFO
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with an acute symptomatic infarction

    Other: MRI scanner · Other: Contrast transoesophageal echocardiography

  • controls with cryptogenic stroke

    Other: MRI scanner · Other: Contrast transoesophageal echocardiography

Interventions

  • OtherMRI scanner

    MRI was performed with a 1.5T magnet (Ingenia, Philips, The Netherlands; diffusion-weighted imaging b-values = 0 and 1,000 s/mm2, TR 4,280 ms, and TE 97 ms). In case of technical problems with the 1.5T MRI scanner, a 3T magnet (Skyra, Siemens, Erlangen, Germany) was used. MRI was analyzed by an experienced rater (DR), blinded to clinical data and MRI sequences other than diffusion-weighted imaging.

  • OtherContrast transoesophageal echocardiography

    Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

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What researchers measure

Primary outcomes

  1. number of infarction lesions

    Number (increase)

    Time frame: day 1

  2. infarction location

    anterior, posterior, or mixed anterior-posterior circulation and the cortical/subcortical/corticosubcortical location of infarction

    Time frame: day 1

  3. size of subcortical lesion

    \< or \>15mm

    Time frame: day 1

  4. presence of multiterritorial infarction

    mixed anterior-posterior circulation or bilateral anterior circulation

    Time frame: day 1

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Study locations

1 site
  • CHU Nîmes
    Nîmes, 30029, France
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References and documents

Publications

  • Renard D, Ion I, Ricci JE, Mura T, Thouvenot E, Wacongne A. Chronic Small Cortical Cerebellar Infarctions on MRI are Associated with Patent Foramen Ovale in Young Cryptogenic Stroke. Cerebrovasc Dis. 2020;49(1):105-109. doi: 10.1159/000505959. Epub 2020 Feb 14. PubMed 32062661 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Dec 2019, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2019
First posted
Aug 2, 2019
StartActual
Jul 25, 2019
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Dec 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04043559
Responsible party
Sponsor
First posted
Aug 2, 2019
Start date
Jul 25, 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Dec 3, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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