Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke (Catch-up-ESUS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Embolic Stroke of Undetermined Source

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 Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80539
    • Recruiting
    • Ludwig Maximilians University
    • Contact: Lars Kellert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of stroke	Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation detection	Through several long-term ECG or ICM	36 months
Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)		36 months
periprocedural events through PFO closure	questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)	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)	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	36 months

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Lars Kellert, Ludwig-Maximilians - University of Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2026

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (ACTUAL): January 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; ESUS; PFO; PFO closure; ICM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Embolic Stroke
• Other Study ID Numbers: 17-685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No