Embolic Stroke of Undetermined Source
Conditions
Keywords
Stroke, ESUS, PFO, PFO closure, ICM
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.
Interventions
None listed
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of stroke | 36 months | Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation detection | 36 months | Through several long-term ECG or ICM |
| Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death) | 36 months | — |
| periprocedural events through PFO closure | 36 months | questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications) |
| Detection of predictors of recurrence of stroke | 36 months | questionnaire with yes or no answer possibilities about cardiovascular risk factors (congestive heart failure, Hypertension, Diabetes mellitus, vascular disease) and their therapy (medication) |
| Collection of predictors for the appearance of atrial fibrillation | 36 months | by laboratory parameters (proBNP), risk stratification of atrial fibrillation in automatic detection, Left atrium size and flow in transthoracic and/or transesophageal echocardiography |
Countries
Germany
Contacts
Primary ContactLars Kellert, MD
Outcome results
None listed