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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820375
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Lars Kellert, 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke (ESUS = Embolic Stroke of Undetermined Source)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2026



Primary Outcome Measures :
  1. Recurrence of stroke [ Time Frame: 36 months ]
    Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms


Secondary Outcome Measures :
  1. Atrial fibrillation detection [ Time Frame: 36 months ]
    Through several long-term ECG or ICM

  2. Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death) [ Time Frame: 36 months ]
  3. periprocedural events through PFO closure [ Time Frame: 36 months ]
    questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)

  4. Detection of predictors of recurrence of stroke [ Time Frame: 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)

  5. Collection of predictors for the appearance of atrial fibrillation [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820375


Contacts
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Contact: Lars Kellert, MD 0049 (0) 89 4400 73962 Lars.Kellert@med.uni-muenchen.de

Locations
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Germany
Ludwig Maximilians University Recruiting
Munich, Germany, 80539
Contact: Lars Kellert, MD         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Lars Kellert Ludwig-Maximilians - University of Munich
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Kellert, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT03820375    
Other Study ID Numbers: 17-685
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lars Kellert, Ludwig-Maximilians - University of Munich:
Stroke
ESUS
PFO
PFO closure
ICM
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases