Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)

Study Overview
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Brief Summary
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STUDY TYPE: Prospective, national , multicenter, and observational study. OBJECTIVE: To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years. DEVICE: Reveal XT 9529 (SQDM) SAMPLE SIZE AND STUDY DURATION: 100 patients enrolled which will be followed during a period of 2 years.

Detailed Description
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Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population

Official Title
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Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder

Conditions
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Atrial Fibrillation, Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients included must meet one of these two conditions: Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging. First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria All patients must meet all of the following: The patient has been implanted an ILR within 30 days after qualifying event Age between 45-85 years No stenosis >50% in any arterial vessel corresponding to the affected territory Normal Echocardiography Normal 24 hours EKG Holter recording Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography) Acceptance and signature of Patient Informed Consent. Exclusion Criteria: All patients included cannot meet any of the following conditions: Recurrent stroke or TIA Stroke or TIA with determined etiology according to TOAST criteria. Anticoagulation indication at the time of enrollment in the study. Total contraindication for anticoagulation therapy Atrial fibrillation detection prior to enrollment Severe cognitive impairment or dementia Patient unable to be followed up Patients enrolled in another clinical trial Patients with life expectancy of less than 1 year Pregnancy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes. |  | Patients will be followed up during two years, regardless of reaching or not the primary endpoint. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All subsequent AF episodes detected by the ILR after primary outcome (AF burden) |  | Patients will be followed up during two years | 
| AF episodes detected by external monitoring |  | Patients will be followed up during two years | 
| Presence of stroke, recurrent TIA, or silent infarction in neuroimaging |  | Patients will be followed up during two years | 
| Changes in anticoagulant therapy |  | Patients will be followed up during two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Cryptogenic stroke, Implantable loop recorder