<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/NCT02240056</url>
  </required_header>
  <id_info>
    <org_study_id>TAKINSULA</org_study_id>
    <nct_id>NCT02240056</nct_id>
  </id_info>
  <brief_title>Brain fMRT In Takotsubo Cardiomyopathy</brief_title>
  <acronym>TAKINSULA</acronym>
  <official_title>Pilot Study: Central Nervous System and Hormonal Changes In Takotsubo Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfgang Dichtl, MD PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Certain cardiac and neurologic diseases influence each other via a still poorly understood&#xD;
      &quot;brain-heart axis&quot;. Subarachnoidal bleedings are well known to cause ECG alterations&#xD;
      resembling those of myocardial infarction, along with a reduction of systolic myocardial&#xD;
      function (&quot;neurogenic stunned myocardium&quot;). Alterations of the right insula region by a&#xD;
      stroke or intracranial hemorrhage go along with a sympathetic activation (increased&#xD;
      circulating catecholamine levels, tachycardia, arterial hypertension). In contrast,&#xD;
      alterations of the left insula region often cause vagal reactions such as bradycardia,&#xD;
      arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of&#xD;
      heart attacks, often caused by psychological or physical stress (death of a beloved one,&#xD;
      divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects&#xD;
      postmenopausal women.&#xD;
&#xD;
      Functional MRT enables imaging of activated brain regions, either without (&quot;resting state&quot;)&#xD;
      or with specific stimuli. The investigators speculate that there is a specific involvement of&#xD;
      the insula region during TTC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Changes in brain functional MRT (resting state, paradigma) in postmenopausal females suffering from TTC as compared to NSTEMI / STEMI postmenopausal female patients</measure>
    <time_frame>Within the first 72h after diagnosis and after 4-8 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Takotsubo Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>TTC</arm_group_label>
    <description>postmenopausal women with acute Takotsubo cardiomyopathy (TTC), diagnosis by coronary angiography within 24 hours of symptom onset</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NSTEMI / STEMI</arm_group_label>
    <description>postmenopausal women with acute ST elevation myocardial infarction (NSTEMI / STEMI), diagnosis by coronary angiography within 24 hours of symptom onset</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy subjects</arm_group_label>
    <description>healthy postmenopausal women without coronary artery disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Postmenopausal women with TTC or NSTEMI / STEMI aged below 90 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal females aged below 90 years&#xD;
&#xD;
          -  Informed written consent&#xD;
&#xD;
          -  TTC or NSTEMI / STEMI undergoing coronary angiography within 24 hours of symptom onset&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Delayed coronary angiography (&gt; 24 hours after symptom onset)&#xD;
&#xD;
          -  Inability to perform rsfMRT within the first 72 hours after coronary angiography&#xD;
&#xD;
          -  Inability to communicate in German language&#xD;
&#xD;
          -  Contraindications for a MRT examination (including pacemaker, implantable&#xD;
             cardioverter-defibrillator, mechanical heart valves, claustrophobia, severe&#xD;
             adipositas)&#xD;
&#xD;
          -  Drug addiction, under guardianship&#xD;
&#xD;
          -  Inability to stick to the follow up examination&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolfgang Dichtl, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Wolfgang Dichtl, MD PhD</investigator_full_name>
    <investigator_title>Priv.Doz. DDr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Takotsubo Cardiomyopathy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02240056
org study id: TAKINSULA
nct id: NCT02240056
lead sponsor: 
has dmc: No
Certain cardiac and neurologic diseases influence each other via a still poorly understood
      "brain-heart axis". Subarachnoidal bleedings are well known to cause ECG alterations
      resembling those of myocardial infarction, along with a reduction of systolic myocardial
      function ("neurogenic stunned myocardium"). Alterations of the right insula region by a
      stroke or intracranial hemorrhage go along with a sympathetic activation (increased
      circulating catecholamine levels, tachycardia, arterial hypertension). In contrast,
      alterations of the left insula region often cause vagal reactions such as bradycardia,
      arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of
      heart attacks, often caused by psychological or physical stress (death of a beloved one,
      divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects
      postmenopausal women.

      Functional MRT enables imaging of activated brain regions, either without ("resting state")
      or with specific stimuli. The investigators speculate that there is a specific involvement of
      the insula region during TTC.
observational model: Cohort
time perspective: Prospective
measure: Changes in brain functional MRT (resting state, paradigma) in postmenopausal females suffering from TTC as compared to NSTEMI / STEMI postmenopausal female patients
time frame: Within the first 72h after diagnosis and after 4-8 weeks
arm group label: TTC
description: postmenopausal women with acute Takotsubo cardiomyopathy (TTC), diagnosis by coronary angiography within 24 hours of symptom onset
arm group label: NSTEMI / STEMI
description: postmenopausal women with acute ST elevation myocardial infarction (NSTEMI / STEMI), diagnosis by coronary angiography within 24 hours of symptom onset
arm group label: healthy subjects
description: healthy postmenopausal women without coronary artery disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: 90 Years
healthy volunteers: No
last name: Wolfgang Dichtl, MD PhD
role: Principal Investigator
affiliation: Medical University Innsbruck
facility: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Wolfgang Dichtl, MD PhD
investigator title: Priv.Doz. DDr.
mesh term: Cardiomyopathies
mesh term: Takotsubo Cardiomyopathy