<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/NCT03246256</url>
  </required_header>
  <id_info>
    <org_study_id>EA4/140/16</org_study_id>
    <nct_id>NCT03246256</nct_id>
  </id_info>
  <brief_title>Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.</brief_title>
  <official_title>Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Neurology, Charité - Universitätsmedizin Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      The aim of the study is to investigate the ability to recall information given during&#xD;
      informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this prospective multi-center study is to investigate whether patients with&#xD;
      acute ischaemic stroke are able to recall information given before providing informed consent&#xD;
      to intravenous thrombolysis after the end of treatment. Patients with acute ischaemic stroke&#xD;
      will be compared to a group of relatives who witnessed the informed consent procedure of a&#xD;
      relative with acute ischaemic stroke, stroke patients who were not treated with intravenous&#xD;
      thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to&#xD;
      the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin,&#xD;
      Germany).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke</measure>
    <time_frame>Within 24 hours</time_frame>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Patients with acute ischaemic stroke who were administered intavenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis; recall in both cases 60 to 90 minutes after the informed consent procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <description>Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <description>Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 1</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
    <other_name>Group 2</other_name>
    <other_name>Group 3</other_name>
    <other_name>Group 4</other_name>
    <other_name>Group 5</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute ischaemic stroke and intravenous thrombolysis or patients with acute&#xD;
        ischaemic stroke refusing intravenous thrombolysis, relatives (1st or 2nd degree) of&#xD;
        patients with acute ischaemic stroke, patient with acute or subacute ischaemic stroke with&#xD;
        a contraindication for intravenous thrombolysis and patients without acute ischaemic stroke&#xD;
        (admitted to the Department of Cardiology (Charité, Campus Benjamin Franklin, Germany).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria (all):&#xD;
&#xD;
          -  age ≥18 years&#xD;
&#xD;
          -  able to give informed consent&#xD;
&#xD;
          -  ability to understand and read German&#xD;
&#xD;
          -  no prior i.v.-thrombolysis&#xD;
&#xD;
        Additional inclusion criteria - patients with acute ischaemic stroke:&#xD;
&#xD;
          -  suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic&#xD;
             stroke&#xD;
&#xD;
          -  indication for intravenous thrombolysis&#xD;
&#xD;
        Additional inclusion criteria - relatives:&#xD;
&#xD;
        · relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during&#xD;
        the informed consent procedure&#xD;
&#xD;
        Additional inclusion criteria - stroke patients with a contraindication for thrombolysis:&#xD;
&#xD;
          -  ischaemic stroke (according to brain MRI or CT)&#xD;
&#xD;
          -  contraindication for intravenous thrombolysis&#xD;
&#xD;
        Additional inclusion criteria - non-stroke patients:&#xD;
&#xD;
        · present admission at the Department of Cardiology and Pneumology, Charité -&#xD;
        Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany&#xD;
&#xD;
        Exclusion criteria (all groups):&#xD;
&#xD;
          -  not able to give imformed consent or under legal supervision/guardianship&#xD;
&#xD;
          -  participation in an interventional 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>
  <location>
    <facility>
      <name>Department of Neurology, University Hospital Würzburg</name>
      <address>
        <city>Würzburg</city>
        <state>Bavaria</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, University Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Saxonia</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Ludwigshafen a. Rh.</name>
      <address>
        <city>Ludwigshafen am Rhein</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuerzburg University Hospital</investigator_affiliation>
    <investigator_full_name>Karl Georg Haeusler</investigator_full_name>
    <investigator_title>Consultant Neurologist</investigator_title>
  </responsible_party>
  <keyword>acute</keyword>
  <keyword>informed consent</keyword>
  <keyword>thrombolysis</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>
  </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/NCT03246256
org study id: EA4/140/16
nct id: NCT03246256
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the ability to recall information given during
      informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.
The purpose of this prospective multi-center study is to investigate whether patients with
      acute ischaemic stroke are able to recall information given before providing informed consent
      to intravenous thrombolysis after the end of treatment. Patients with acute ischaemic stroke
      will be compared to a group of relatives who witnessed the informed consent procedure of a
      relative with acute ischaemic stroke, stroke patients who were not treated with intravenous
      thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to
      the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin,
      Germany).
observational model: Other
time perspective: Prospective
measure: Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke
time frame: Within 24 hours
arm group label: Group 1
description: Patients with acute ischaemic stroke who were administered intavenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis; recall in both cases 60 to 90 minutes after the informed consent procedure
arm group label: Group 2
description: 1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure
arm group label: Group 3
description: Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis
arm group label: Group 4
description: Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)
arm group label: Group 5
description: Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure
intervention type: Other
intervention name: Group 1
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
other name: Group 2
other name: Group 3
other name: Group 4
other name: Group 5
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Wuerzburg University Hospital
investigator full name: Karl Georg Haeusler
investigator title: Consultant Neurologist
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No