xml: <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/NCT05977049</url>
    </required_header>
    <id_info>
      <org_study_id>23-04025981</org_study_id>
      <nct_id>NCT05977049</nct_id>
    </id_info>
    <brief_title>Psychosocial Support for Patients With Takotsubo Syndrome</brief_title>
    <official_title>Psychosocial Support for Patients With Takotsubo Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Weill Medical College of Cornell University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Weill Medical College of Cornell University</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 study hypothesis is that participants enrolled in a virtual Takotsubo support group will&#xD;
        have significantly less anxiety at one year.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Takotsubo cardiomyopathy, sometimes termed Takotsubo syndrome and &quot;broken heart syndrome,&quot;&#xD;
        typically presents with symptoms remarkably similar to acute myocardial infarction (MI; heart&#xD;
        attack): debilitating chest pain, shortness of breath, and a feeling of doom, among others.&#xD;
        Takotsubo was first identified in 1990 in Japan. Most cases occur in older women. During the&#xD;
        acute phase, the heart spontaneously undergoes &quot;apical ballooning,&quot; changing shape to&#xD;
        resemble a &quot;takotsubo,&quot; a Japanese octopus trap. In approximately two-thirds of cases,&#xD;
        Takotsubo is precipitated by an intense emotional or physical &quot;trigger.&quot; Typically, the heart&#xD;
        spontaneously reverts to its previous shape within about a month. Initially, it was thought&#xD;
        that recurrence was rare. However, more recently, recurrences have been reported in 3-15% of&#xD;
        cases. Many patients experience a variety of debilitating cardiac and psychological symptoms&#xD;
        long after the initial presentation. There is no known way to prevent a recurrent event and&#xD;
        patients are typically anxious about the possibility.&#xD;
  &#xD;
        Since its inception as a diagnosis, one of the hallmarks of Takotsubo has been the absence of&#xD;
        coronary artery plaque. In a surprising finding from 2019, a study of more than 1,000&#xD;
        Takotsubo patients undergoing coronary angiography reported that approximately 1/3 of&#xD;
        patients had clinically significant plaque in their coronary arteries; 1/3 had evidence of&#xD;
        sub-clinical atherosclerosis; and 1/3 had &quot;clean coronaries,&quot; with no observable plaque.&#xD;
        Hence, much needs to be learned about this syndrome that may affect as many as 5% of women&#xD;
        who have been diagnosed with acute MI. Takotsubo is typically an emotionally challenging and&#xD;
        life altering event. Strategies for primary and secondary prevention of coronary artery&#xD;
        disease will be discussed in the virtual group sessions.&#xD;
  &#xD;
        Currently, there is no specialized intervention for patients diagnosed with Takotsubo&#xD;
        Syndrome at Weill Cornell Medical Center, either in hospital or after discharge.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>All subjects will be placed in a virtual Takotsubo Support Group once enrolled in the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in anxiety level as measured by the STAI.</measure>
      <time_frame>Baseline, One year</time_frame>
      <description>State Trait Anxiety Inventory (STAI):&#xD;
  Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in depression as measured by the PHQ-8.</measure>
      <time_frame>Baseline, One year</time_frame>
      <description>Patient Health Questionnaire depression scale (PHQ-8):&#xD;
  Score of 0-2 = No Depression; Score of 3-5 = Mild Depression; Score of 6-8 = Moderate Depression; Score of 9-12 = Severe Depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in quality of life as measured by the KCCQ.</measure>
      <time_frame>Baseline, One year</time_frame>
      <description>Kansas City Quality of Life Questionnaire (KCCQ):&#xD;
  Score of 0-24 = Very poor to poor quality of life; Score of 25-49 = Poor to fair quality of life; Score of 50-74 = Fair to good quality of life; Score of 75-100 = Good to excellent quality of life</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Takotsubo Cardiomyopathy</condition>
    <arm_group>
      <arm_group_label>Takotsubo Support Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Takotsubo Support Group</intervention_name>
      <description>Participants will undergo virtual group therapy/education. Participants will meet once every other week (at minimum), for 1 - 1.5 hours (on average). The frequency and/or length of the support group sessions may be adjusted according to participants' needs.</description>
      <arm_group_label>Takotsubo Support Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or&#xD;
               those who choose not to participate.&#xD;
  &#xD;
            -  Vulnerable populations such as prisoners, non-English speaking subjects, pregnant&#xD;
               women, and subjects unable to provide written informed consent will not be included in&#xD;
               this research.&#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>Jim Cheung, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Weill Medical College of Cornell University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Glum, BSN, MPA</last_name>
      <phone>212-746-4617</phone>
      <email>hep2011@med.cornell.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dolores Reynolds, BSN</last_name>
      <phone>212-746-4617</phone>
      <email>dtr2001@med.cornell.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Weill Cornell Medicine</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10021</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Heather Glum, BSN, MPA</last_name>
        <email>hep2011@med.cornell.edu</email>
      </contact>
      <contact_backup>
        <last_name>Dolores Reynolds, BSN</last_name>
        <phone>212-746-4617</phone>
        <email>dtr2001@med.cornell.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Jim Cheung, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Sato, H., et al. (1990) Takotsubo-type cardiomyopathy due to multivessel spasm. In: Kodama, K., Haze, K., Hon M, et al., Eds., Clinical Aspect of Myocardial Injury: From Ischemia to Heart Failure, Kagakuhyouronsha, Tpkyo, 56-64.</citation>
    </reference>
    <reference>
      <citation>Ghadri JR, Wittstein IS, Prasad A, Sharkey S, Dote K, Akashi YJ, Cammann VL, Crea F, Galiuto L, Desmet W, Yoshida T, Manfredini R, Eitel I, Kosuge M, Nef HM, Deshmukh A, Lerman A, Bossone E, Citro R, Ueyama T, Corrado D, Kurisu S, Ruschitzka F, Winchester D, Lyon AR, Omerovic E, Bax JJ, Meimoun P, Tarantini G, Rihal C, Y-Hassan S, Migliore F, Horowitz JD, Shimokawa H, Luscher TF, Templin C. International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology. Eur Heart J. 2018 Jun 7;39(22):2032-2046. doi: 10.1093/eurheartj/ehy076.</citation>
      <PMID>29850871</PMID>
    </reference>
    <reference>
      <citation>Napp LC, Cammann VL, Jaguszewski M, Szawan KA, Wischnewsky M, Gili S, Knorr M, Heiner S, Citro R, Bossone E, D'Ascenzo F, Neuhaus M, Franke J, Sorici-Barb I, Noutsias M, Burgdorf C, Koenig W, Kherad B, Sarcon A, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Pott A, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Hauck C, Paolini C, Bilato C, Imori Y, Kato K, Kobayashi Y, Opolski G, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, El-Battrawy I, Akin I, Gilyarova E, Shilova A, Gilyarov M, Horowitz JD, Polednikova K, Tousek P, Widimsky P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Di Mario C, Prasad A, Rihal CS, Schulze PC, Bianco M, Crea F, Borggrefe M, Maier LS, Pinto FJ, Braun-Dullaeus RC, Rottbauer W, Katus HA, Hasenfuss G, Tschope C, Pieske BM, Thiele H, Schunkert H, Bohm M, Felix SB, Munzel T, Bax JJ, Bauersachs J, Braunwald E, Luscher TF, Ruschitzka F, Ghadri JR, Templin C. Coexistence and outcome of coronary artery disease in Takotsubo syndrome. Eur Heart J. 2020 Sep 7;41(34):3255-3268. doi: 10.1093/eurheartj/ehaa210.</citation>
      <PMID>32484517</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Takotsubo</keyword>
    <keyword>Cardiomyopathy</keyword>
    <keyword>Takotsubo Syndrome</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977049
  org study id: 23-04025981
  nct id: NCT05977049
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study hypothesis is that participants enrolled in a virtual Takotsubo support group will
        have significantly less anxiety at one year.
  Takotsubo cardiomyopathy, sometimes termed Takotsubo syndrome and "broken heart syndrome,"
        typically presents with symptoms remarkably similar to acute myocardial infarction (MI; heart
        attack): debilitating chest pain, shortness of breath, and a feeling of doom, among others.
        Takotsubo was first identified in 1990 in Japan. Most cases occur in older women. During the
        acute phase, the heart spontaneously undergoes "apical ballooning," changing shape to
        resemble a "takotsubo," a Japanese octopus trap. In approximately two-thirds of cases,
        Takotsubo is precipitated by an intense emotional or physical "trigger." Typically, the heart
        spontaneously reverts to its previous shape within about a month. Initially, it was thought
        that recurrence was rare. However, more recently, recurrences have been reported in 3-15% of
        cases. Many patients experience a variety of debilitating cardiac and psychological symptoms
        long after the initial presentation. There is no known way to prevent a recurrent event and
        patients are typically anxious about the possibility.
  
        Since its inception as a diagnosis, one of the hallmarks of Takotsubo has been the absence of
        coronary artery plaque. In a surprising finding from 2019, a study of more than 1,000
        Takotsubo patients undergoing coronary angiography reported that approximately 1/3 of
        patients had clinically significant plaque in their coronary arteries; 1/3 had evidence of
        sub-clinical atherosclerosis; and 1/3 had "clean coronaries," with no observable plaque.
        Hence, much needs to be learned about this syndrome that may affect as many as 5% of women
        who have been diagnosed with acute MI. Takotsubo is typically an emotionally challenging and
        life altering event. Strategies for primary and secondary prevention of coronary artery
        disease will be discussed in the virtual group sessions.
  
        Currently, there is no specialized intervention for patients diagnosed with Takotsubo
        Syndrome at Weill Cornell Medical Center, either in hospital or after discharge.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All subjects will be placed in a virtual Takotsubo Support Group once enrolled in the study.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in anxiety level as measured by the STAI.
  time frame: Baseline, One year
  description: State Trait Anxiety Inventory (STAI):
  Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety
  measure: Changes in depression as measured by the PHQ-8.
  time frame: Baseline, One year
  description: Patient Health Questionnaire depression scale (PHQ-8):
  Score of 0-2 = No Depression; Score of 3-5 = Mild Depression; Score of 6-8 = Moderate Depression; Score of 9-12 = Severe Depression
  measure: Changes in quality of life as measured by the KCCQ.
  time frame: Baseline, One year
  description: Kansas City Quality of Life Questionnaire (KCCQ):
  Score of 0-24 = Very poor to poor quality of life; Score of 25-49 = Poor to fair quality of life; Score of 50-74 = Fair to good quality of life; Score of 75-100 = Good to excellent quality of life
  arm group label: Takotsubo Support Group
  arm group type: Other
  description: Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.
  intervention type: Behavioral
  intervention name: Takotsubo Support Group
  description: Participants will undergo virtual group therapy/education. Participants will meet once every other week (at minimum), for 1 - 1.5 hours (on average). The frequency and/or length of the support group sessions may be adjusted according to participants' needs.
  arm group label: Takotsubo Support Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jim Cheung, MD
  role: Principal Investigator
  affiliation: Weill Medical College of Cornell University
  last name: Heather Glum, BSN, MPA
  phone: 212-746-4617
  email: hep2011@med.cornell.edu
  last name: Dolores Reynolds, BSN
  phone: 212-746-4617
  email: dtr2001@med.cornell.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Sato, H., et al. (1990) Takotsubo-type cardiomyopathy due to multivessel spasm. In: Kodama, K., Haze, K., Hon M, et al., Eds., Clinical Aspect of Myocardial Injury: From Ischemia to Heart Failure, Kagakuhyouronsha, Tpkyo, 56-64.
  citation: Ghadri JR, Wittstein IS, Prasad A, Sharkey S, Dote K, Akashi YJ, Cammann VL, Crea F, Galiuto L, Desmet W, Yoshida T, Manfredini R, Eitel I, Kosuge M, Nef HM, Deshmukh A, Lerman A, Bossone E, Citro R, Ueyama T, Corrado D, Kurisu S, Ruschitzka F, Winchester D, Lyon AR, Omerovic E, Bax JJ, Meimoun P, Tarantini G, Rihal C, Y-Hassan S, Migliore F, Horowitz JD, Shimokawa H, Luscher TF, Templin C. International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology. Eur Heart J. 2018 Jun 7;39(22):2032-2046. doi: 10.1093/eurheartj/ehy076.
  PMID: 29850871
  citation: Napp LC, Cammann VL, Jaguszewski M, Szawan KA, Wischnewsky M, Gili S, Knorr M, Heiner S, Citro R, Bossone E, D'Ascenzo F, Neuhaus M, Franke J, Sorici-Barb I, Noutsias M, Burgdorf C, Koenig W, Kherad B, Sarcon A, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Pott A, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Hauck C, Paolini C, Bilato C, Imori Y, Kato K, Kobayashi Y, Opolski G, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, El-Battrawy I, Akin I, Gilyarova E, Shilova A, Gilyarov M, Horowitz JD, Polednikova K, Tousek P, Widimsky P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Di Mario C, Prasad A, Rihal CS, Schulze PC, Bianco M, Crea F, Borggrefe M, Maier LS, Pinto FJ, Braun-Dullaeus RC, Rottbauer W, Katus HA, Hasenfuss G, Tschope C, Pieske BM, Thiele H, Schunkert H, Bohm M, Felix SB, Munzel T, Bax JJ, Bauersachs J, Braunwald E, Luscher TF, Ruschitzka F, Ghadri JR, Templin C. Coexistence and outcome of coronary artery disease in Takotsubo syndrome. Eur Heart J. 2020 Sep 7;41(34):3255-3268. doi: 10.1093/eurheartj/ehaa210.
  PMID: 32484517
  responsible party type: Sponsor
  mesh term: Cardiomyopathies
  mesh term: Takotsubo Cardiomyopathy
  sharing ipd: No