<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03820375</url>
  </required_header>
  <id_info>
    <org_study_id>17-685</org_study_id>
    <nct_id>NCT03820375</nct_id>
  </id_info>
  <brief_title>Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke</brief_title>
  <acronym>Catch-up-ESUS</acronym>
  <official_title>Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke (ESUS = Embolic Stroke of Undetermined Source)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to know, there is no clear diagnostic and therapeutic pathway for patients with embolic&#xD;
      stroke of undetermined source (ESUS). This prospective registry study, which follows up adult&#xD;
      ESUS patients for 36 months, is intended to provide important data for the detection of an&#xD;
      individual approach in ESUS patients based on a structured diagnostic and therapeutic&#xD;
      pathway.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The open-label, academic, prospective, monocentric, observational registry-study&#xD;
      (Catch-up-ESUS registry study) started in 01/2018. All ESUS-patients (≥18 years) treated in&#xD;
      our hospital are included and will be followed up for three years. Depending on age (&lt; 60&#xD;
      years or ≥ 60 years), the patients are processed according to a standardized treatment&#xD;
      algorithm designed interdisciplinary by neurologists and cardiologists. An insertable cardiac&#xD;
      monitor (ICM) is implanted in all of them by default. Patients &lt; 60 years without evidence of&#xD;
      atrial fibrillation and co-existing PFO are planned for PFO closure within 6 months after&#xD;
      stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>36 Months</target_duration>
  <primary_outcome>
    <measure>Recurrence of stroke</measure>
    <time_frame>36 months</time_frame>
    <description>Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation detection</measure>
    <time_frame>36 months</time_frame>
    <description>Through several long-term ECG or ICM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>periprocedural events through PFO closure</measure>
    <time_frame>36 months</time_frame>
    <description>questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of predictors of recurrence of stroke</measure>
    <time_frame>36 months</time_frame>
    <description>questionnaire with yes or no answer possibilities about cardiovascular risk factors (congestive heart failure, Hypertension, Diabetes mellitus, vascular disease) and their therapy (medication)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of predictors for the appearance of atrial fibrillation</measure>
    <time_frame>36 months</time_frame>
    <description>by laboratory parameters (proBNP), risk stratification of atrial fibrillation in automatic detection, Left atrium size and flow in transthoracic and/or transesophageal echocardiography</description>
  </secondary_outcome>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Embolic Stroke of Undetermined Source</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients (≥18 years) treated in our hospital and diagnosed with an ESUS will be&#xD;
        collected.&#xD;
&#xD;
        An extension to additional centres is planned in the course of the project, if good&#xD;
        feasibility can be demonstrated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Embolic stroke of undetermined source or cryptogenic stroke; defined as: non-lacunar&#xD;
             brain infarction without proximal arterial stenosis or cardioembolic source or other&#xD;
             etiology (e.g. vasculitis, cervical artery dissection)&#xD;
&#xD;
          -  ≥18 years&#xD;
&#xD;
          -  written consent to participation in the study register by the patient or the legal&#xD;
             guardian or authorised representative at the time of inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Kellert</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lars Kellert, MD</last_name>
    <phone>0049 (0) 89 4400 73962</phone>
    <email>Lars.Kellert@med.uni-muenchen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ludwig Maximilians University</name>
      <address>
        <city>Munich</city>
        <zip>80539</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lars Kellert, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Lars Kellert</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>ESUS</keyword>
  <keyword>PFO</keyword>
  <keyword>PFO closure</keyword>
  <keyword>ICM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Embolic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03820375
org study id: 17-685
nct id: NCT03820375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Recurrence of stroke
time frame: 36 months
description: Detection of recurrence of ischemia in CT or MRT imaging due to new clinical symptoms
measure: Atrial fibrillation detection
time frame: 36 months
description: Through several long-term ECG or ICM
measure: Frequency of other vascular events depending on therapy (e.g. myocardial infarction, vascular death)
time frame: 36 months
measure: periprocedural events through PFO closure
time frame: 36 months
description: questionnaire with yes or no answer possibilities (stroke, systemic embolism, atrial fibrillation, bleeding complications)
measure: Detection of predictors of recurrence of stroke
time frame: 36 months
description: questionnaire with yes or no answer possibilities about cardiovascular risk factors (congestive heart failure, Hypertension, Diabetes mellitus, vascular disease) and their therapy (medication)
measure: Collection of predictors for the appearance of atrial fibrillation
time frame: 36 months
description: by laboratory parameters (proBNP), risk stratification of atrial fibrillation in automatic detection, Left atrium size and flow in transthoracic and/or transesophageal echocardiography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Kellert
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
last name: Lars Kellert, MD
phone: 0049 (0) 89 4400 73962
email: Lars.Kellert@med.uni-muenchen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Lars Kellert
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Embolic Stroke
sharing ipd: No