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

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ClinicalTrials.gov Identifier: NCT04043559
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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.

Condition or disease Intervention/treatment
Brain Infarction Other: MRI scanner Other: Contrast transoesophageal echocardiography

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Small Cortical Cerebellar Infarctions Are Associated With Patent Foramen Ovale in Young Cryptogenic Stroke Patients
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Group/Cohort Intervention/treatment
patients with an acute symptomatic infarction Other: 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.

Other: Contrast transoesophageal echocardiography
Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

controls with cryptogenic stroke Other: 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.

Other: Contrast transoesophageal echocardiography
Contrast transoesophageal echocardiography (including Valsalva manoeuvre)




Primary Outcome Measures :
  1. number of infarction lesions [ Time Frame: day 1 ]
    Number (increase)

  2. infarction location [ Time Frame: day 1 ]
    anterior, posterior, or mixed anterior-posterior circulation and the cortical/subcortical/corticosubcortical location of infarction

  3. size of subcortical lesion [ Time Frame: day 1 ]
    < or >15mm

  4. presence of multiterritorial infarction [ Time Frame: day 1 ]
    mixed anterior-posterior circulation or bilateral anterior circulation



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043559


Contacts
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Contact: Dimitri RENARD 04 66 68 32 61 dimitri.renard@chu-nimes.fr

Locations
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France
CHU Nîmes Recruiting
Nîmes, France, 30029
Contact: Dimitri RENARD    04 66 68 32 61    dimitri.renard@chu-nimes.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04043559     History of Changes
Other Study ID Numbers: Local/2019/DR-01
IRB 24/07/2019 ( Other Identifier: IRB CHU Nîmes )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Infarction
Foramen Ovale, Patent
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases