Brain MRI in Stroke Patients With Intracardiac Thrombus (BRAIN IRM)

November 18, 2020 updated by: Centre Hospitalier Universitaire de Nīmes

Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus

Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU de Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

2 groups of patients :

1 - Stroke patients with atrial fibrillation

2- Stroke patients with intracardiac thrombus

Description

Inclusion Criteria:

  • consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period.
  • Brain MRI (including diffusion-weighted imaging [DWI]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight [TOF], gadolinium-enhanced magnetic resonance angiography [MRA], or computed tomographic angiography [CTA]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).

Exclusion Criteria:

  • opt-out patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation
stroke patients with atrial fibrillation
Other: No intervention,
pure observational study
Intracardiac thrombus
stroke patients with intracardiac thrombus
Other: No intervention,
pure observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI characteristics
Time Frame: Day of inclusion (Day 1)
infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions [SCCI] or non-SCCI; cortical/subcortical/corticosubcortical)
Day of inclusion (Day 1)
Brain MRI characteristics
Time Frame: Day of inclusion (Day 1)
lesion number
Day of inclusion (Day 1)
Brain MRI characteristics
Time Frame: Day of inclusion (Day 1)
subcortical lesion size (><15 mm)
Day of inclusion (Day 1)
Brain MRI characteristics
Time Frame: Day of inclusion (Day 1)
total infarction volume.
Day of inclusion (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Dimitri RENARD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2020/DR-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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