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

N/AUnknownNCT03820375

Ludwig-Maximilians - University of Munich750 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

750

Conditions

Embolic Stroke of Undetermined Source

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ludwig Maximilians University

Munich, Germany

RECRUITING

Outcomes

Primary Outcomes

Recurrence of stroke

Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms

Time frame: 36 months

Secondary Outcomes

Atrial fibrillation detection

Through several long-term ECG or ICM

Time frame: 36 months

Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)

Time frame: 36 months

periprocedural events through PFO closure

questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)

Time frame: 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)

Time frame: 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

Time frame: 36 months

Central Contacts

Lars Kellert, MD

CONTACT

0049 (0) 89 4400 73962 Lars.Kellert@med.uni-muenchen.de

Data from ClinicalTrials.gov

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