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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)

Primary Purpose

Stroke, Implantation of an Implantable Cardiac Monitor

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac MRI (with contrast agent)
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient who has provided free, written and informed consent Patient of legal age Patient with cryptogenic ischemic stroke within 7 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

Sites / Locations

  • Chu Dijon Bourgogne

Outcomes

Primary Outcome Measures

Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
September 14, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT06047782
Brief Title
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.
Acronym
FIBROSIS-MRI
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2028 (Anticipated)
Study Completion Date
October 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Implantation of an Implantable Cardiac Monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Cardiac MRI (with contrast agent)
Intervention Description
Cardiac MRI with contrast agent
Primary Outcome Measure Information:
Title
Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder
Time Frame
at 3-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient who has provided free, written and informed consent Patient of legal age Patient with cryptogenic ischemic stroke within 7 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles GUENANCIA
Phone
0380295623
Email
charles.guenancia@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles GUENANCIA
Phone
0380295623
Email
charles.guenancia@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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.

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