NCT03820375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

5 years

First QC Date

January 14, 2019

Last Update Submit

January 28, 2019

Conditions

Keywords

StrokeESUSPFOPFO closureICM

Outcome Measures

Primary Outcomes (1)

  • Recurrence of stroke

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

    36 months

Secondary Outcomes (5)

  • Atrial fibrillation detection

    36 months

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

    36 months

  • periprocedural events through PFO closure

    36 months

  • Detection of predictors of recurrence of stroke

    36 months

  • Collection of predictors for the appearance of atrial fibrillation

    36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Maximilians University

Munich, 80539, Germany

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lars Kellert

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 29, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2023

Study Completion

January 1, 2026

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations