Evaluating how atrial fibrosis affects atrial fibrillation risk in stroke patients
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.
NA · Centre Hospitalier Universitaire Dijon · NCT06047782
This study is trying to see if measuring heart tissue damage can help identify stroke patients who are at risk for developing atrial fibrillation and might benefit from better monitoring.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon (other) |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06047782 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the surface area of atrial fibrosis and the occurrence of atrial fibrillation in patients who have experienced an ischemic stroke of unknown origin. It utilizes cardiac MRI imaging to assess the left atrium and aims to improve the selection process for patients who may benefit from implantable loop recorders. By identifying patients at higher risk for atrial fibrillation, the study seeks to enhance long-term monitoring and treatment strategies. The study involves patients who have had a cryptogenic ischemic stroke within the last 30 days and are scheduled for loop recorder implantation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who have experienced a cryptogenic ischemic stroke within the last 30 days and are scheduled for an implantable loop recorder.
Not a fit: Patients who have a history of atrial fibrillation or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more targeted and effective monitoring of atrial fibrillation in stroke patients, potentially reducing the risk of future strokes.
How similar studies have performed: While the use of cardiac MRI in this context is innovative, similar studies have shown promise in identifying atrial fibrillation risk factors in stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (RECRUITING)
Study contacts
- Study coordinator: Charles GUENANCIA
- Email: charles.guenancia@chu-dijon.fr
- Phone: 0380295623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Implantation of an Implantable Cardiac Monitor