Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study. (FIBROSIS-MRI)

January 16, 2026 updated by: Centre Hospitalier Universitaire Dijon

Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Atrial fibrillation is a major cause of stroke, accounting for more than 25% of all strokes. In addition, a quarter of ischemic strokes remain without an obvious cause at the end of hospitalization, and it is recommended that atrial fibrillation be detected intensively with long-term heart rhythm recording. Implantable loop recorders can detect 30% of atrial fibrillation cases over the 3-year battery life of these devices, after a stroke of undetermined origin. However, these devices require a small operation to implant them under the skin, and they are expensive.

The hypothesis of this study is that MRI imaging of the left atrium would enable better selection of patients to receive an implantable loop recorder. MRI can quantify the proportion of the left atrium with scar tissue, which is likely to favour the onset of atrial fibrillation. If the results confirm this hypothesis, the number of patients requiring an implantable loop recorder could be reduced, and perhaps an anticoagulation strategy based on MRI data could be introduced.

In addition to the usual follow-up by cardiologists and neurologists, participation in this study involves a cardiac MRI (with contrast agent) within 3 months of the stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient who has provided free, written and informed consent
  • Patient of legal age
  • Patient with cryptogenic ischemic stroke within 30 days of inclusion, documented by brain imaging (cerebral angioscan or cerebral MRI)

  • Patients scheduled for implantable loop recorder implantation within 3 months of ischemic stroke in search of silent AF:

    • cryptogenic ischemic stroke or stroke with probable cardioembolic cause
    • no history of atrial fibrillation
    • no long-term anticoagulant therapy
    • with life expectancy >12 months

Exclusion Criteria:

  • Person not affiliated to national health insurance
  • Person under legal protection (curatorship, guardianship)
  • Person under court order
  • Pregnant, parturient or breast-feeding
  • Adult unable to give consent
  • Patient diagnosed with AF during stroke assessment

  • Patient with a contraindication to MRI or gadolinium injection:

    • Severe renal impairment (<30ml/min Cockroft clearance due to gadolinium injection)
    • Claustrophobia / contraindication to MRI (metal implant not MRI compatible)
    • History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents, and to meglumine
    • Uncontrolled asthma

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder
Time Frame: at 3-year follow-up
at 3-year follow-up

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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)

January 31, 2024

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUENANCIA FRAVC 2022

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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