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

Embolic Stroke of Undetermined Source Clinical Trial

— Catch-up-ESUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820375
• Other study ID #: 17-685
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: Lars Kellert, MD
• Phone: 0049 (0) 89 4400 73962
• Email: Lars.Kellert[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolic Stroke of Undetermined Source
• Stroke

Locations

Country	Name	City	State
Germany	Ludwig Maximilians University	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of stroke	Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms	36 months
Secondary	Atrial fibrillation detection	Through several long-term ECG or ICM	36 months
Secondary	Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)		36 months
Secondary	periprocedural events through PFO closure	questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)	36 months
Secondary	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
Secondary	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