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

Recruiting

• Conditions: Embolic Stroke of Undetermined Source

• Registration Number: NCT03820375
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2023-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of stroke	36 months	Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ludwig Maximilians University; 🇩🇪 Munich, Germany