Clinical trial NCT03820375: Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke
Official title: Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke (ESUS = Embolic Stroke of Undetermined Source)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Embolic Stroke of Undetermined Source
Keywords: Stroke
ESUS
PFO
PFO closure
ICM
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (≥18 years) treated in our hospital and diagnosed with an ESUS will be collected.

An extension to additional centres is planned in the course of the project, if good feasibility can be demonstrated.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of stroke
timeFrame: 36 months
Secondary outcomes:
measure: Atrial fibrillation detection
timeFrame: 36 months
measure: Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)
timeFrame: 36 months
measure: periprocedural events through PFO closure
timeFrame: 36 months
measure: Detection of predictors of recurrence of stroke
timeFrame: 36 months
measure: Collection of predictors for the appearance of atrial fibrillation
timeFrame: 36 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Lars Kellert
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feil K, Heinrich J, Kupper C, Muller K, Laub C, von Falkenhausen AS, Becker R, Wollenweber FA, Kaab S, Sinner MF, Kellert L. Catch-up-ESUS - follow-up in embolic stroke of undetermined source (ESUS) in a prospective, open-label, observational study: study protocol and initial baseline data. BMJ Open. 2019 Dec 9;9(12):e031716. doi: 10.1136/bmjopen-2019-031716.