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

NCT ID: NCT04043559

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-25

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with an acute symptomatic infarction

MRI scanner

Intervention Type OTHER

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.

Contrast transoesophageal echocardiography

Intervention Type OTHER

Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

controls with cryptogenic stroke

MRI scanner

Intervention Type OTHER

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.

Contrast transoesophageal echocardiography

Intervention Type OTHER

Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

Interventions

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MRI 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.

Intervention Type OTHER

Contrast transoesophageal echocardiography

Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nîmes

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 32062661 (View on PubMed)

Other Identifiers

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Local/2019/DR-01

Identifier Type: -

Identifier Source: org_study_id

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