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

NCT04043559 | Completed

• 1 other identifier: Local/2019/DR-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Infarction

Outcome Measures

Primary Outcomes (4)

• number of infarction lesions

  Number (increase)

  day 1

• infarction location

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

  day 1

• size of subcortical lesion

  \< or \>15mm

  day 1

• presence of multiterritorial infarction

  mixed anterior-posterior circulation or bilateral anterior circulation

  day 1

Study Arms (2)

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

MRI scanner 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.

controls with cryptogenic stroke; patients with an acute symptomatic infarction

Contrast transoesophageal echocardiography OTHER

Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

controls with cryptogenic stroke; patients with an acute symptomatic infarction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 32062661 RESULT

MeSH Terms

Conditions

Brain Infarction

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 2, 2019
• Study Start: July 25, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 3, 2025

Record last verified: 2021-09

Locations

FR (1)