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

Brain Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043559
• Other study ID #: Local/2019/DR-01
• Secondary ID: IRB 24/07/2019
• Status: Completed
• Start date: July 25, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Infarction
• Foramen Ovale, Patent
• Infarction

Intervention

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.
• Contrast transoesophageal echocardiography
Contrast transoesophageal echocardiography (including Valsalva manoeuvre)

Locations

Country	Name	City	State
France	CHU Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of infarction lesions	Number (increase)	day 1
Primary	infarction location	anterior, posterior, or mixed anterior-posterior circulation and the cortical/subcortical/corticosubcortical location of infarction	day 1
Primary	size of subcortical lesion	< or >15mm	day 1
Primary	presence of multiterritorial infarction	mixed anterior-posterior circulation or bilateral anterior circulation	day 1