Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke

Study Overview
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Brief Summary
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Up to know, there is no clear diagnostic and therapeutic pathway for patients with embolic stroke of undetermined source (ESUS). This prospective registry study, which follows up adult ESUS patients for 36 months, is intended to provide important data for the detection of an individual approach in ESUS patients based on a structured diagnostic and therapeutic pathway.

Detailed Description
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The open-label, academic, prospective, monocentric, observational registry-study (Catch-up-ESUS registry study) started in 01/2018. All ESUS-patients (≥18 years) treated in our hospital are included and will be followed up for three years. Depending on age (< 60 years or ≥ 60 years), the patients are processed according to a standardized treatment algorithm designed interdisciplinary by neurologists and cardiologists. An insertable cardiac monitor (ICM) is implanted in all of them by default. Patients < 60 years without evidence of atrial fibrillation and co-existing PFO are planned for PFO closure within 6 months after stroke.

Official Title
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Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke (ESUS = Embolic Stroke of Undetermined Source)

Conditions
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Embolic Stroke of Undetermined Source

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Embolic stroke of undetermined source or cryptogenic stroke; defined as: non-lacunar brain infarction without proximal arterial stenosis or cardioembolic source or other etiology (e.g. vasculitis, cervical artery dissection) ≥18 years written consent to participation in the study register by the patient or the legal guardian or authorised representative at the time of inclusion in the study

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of stroke | Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation detection | Through several long-term ECG or ICM | 36 months | 
| Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death) |  | 36 months | 
| periprocedural events through PFO closure | questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications) | 36 months | 
| Detection of predictors of recurrence of stroke | questionnaire with yes or no answer possibilities about cardiovascular risk factors (congestive heart failure, Hypertension, Diabetes mellitus, vascular disease) and their therapy (medication) | 36 months | 
| Collection of predictors for the appearance of atrial fibrillation | by laboratory parameters (proBNP), risk stratification of atrial fibrillation in automatic detection, Left atrium size and flow in transthoracic and/or transesophageal echocardiography | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PFO, Stroke, ESUS, PFO closure, ICM