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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT04043559
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	Phase
Brain Infarction	Other: MRI scanner; Other: Contrast transoesophageal echocardiography

Study Design

• Study Type: Observational
• Actual 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: Jul 25, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. number of infarction lesions [day 1]

   Number (increase)

2. infarction location [day 1]

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

3. size of subcortical lesion [day 1]

   < or >15mm

4. presence of multiterritorial infarction [day 1]

   mixed anterior-posterior circulation or bilateral anterior circulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Nîmes	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT04043559
• Other Study ID Numbers: Local/2019/DR-01; IRB 24/07/2019
• First Posted: Aug 2, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Infarction; Foramen Ovale, Patent; Infarction

Study Results

No Results Posted as of Sep 5, 2021