Status:

RECRUITING

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.

Lead Sponsor:

Centre Hospitalier Universitaire Dijon

Conditions:

Stroke

Implantation of an Implantable Cardiac Monitor

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 thr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 31 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2029

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06047782

Start Date

January 31 2024

End Date

January 1 2029

Last Update

May 8 2024

Active Locations (1)

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1

Chu Dijon Bourgogne

Dijon, France

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. | DecenTrialz