Embolic Stroke of Undetermined SourceCatch-up-ESUSNCT03820375
Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke
An observational study of Embolic Stroke of Undetermined Source, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 1 Jan 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ludwig Maximilians University
Munich, 80539
Lars Kellert, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Stroke, ESUS, PFO, PFO closure, ICM
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of stroke
Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms
Measured: 36 months
Secondary outcomes (5)
Atrial fibrillation detection
Through several long-term ECG or ICM
Measured: 36 months
Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)
Measured: 36 months
periprocedural events through PFO closure
questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)
Measured: 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)
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Kellert, Ludwig-Maximilians - University of Munich
- Investigators
- Lars Kellert, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820375
- Sponsor's protocol ID
- 17-685
- Acronym
- Catch-up-ESUS
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31822542
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke (ESUS = Embolic Stroke of Undetermined Source)
- ClinicalTrials.gov ID
- NCT03820375
- Acronym / sponsor ID
- Catch-up-ESUS / 17-685
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Stroke, ESUS, PFO, PFO closure, ICM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of stroke
Time frame: 36 months
Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms
5 secondary outcomes
Atrial fibrillation detection
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
Time frame: 36 months
Detection of predictors of recurrence of stroke
Time frame: 36 months
Collection of predictors for the appearance of atrial fibrillation
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 31822542Feil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Kellert principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Kellert, MD (0049 (0) 89 4400 73962, Lars.Kellert@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of stroke (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.