<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/NCT03261089</url>
  </required_header>
  <id_info>
    <org_study_id>H-36257</org_study_id>
    <nct_id>NCT03261089</nct_id>
  </id_info>
  <brief_title>Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository</brief_title>
  <acronym>MOCHA</acronym>
  <official_title>MOCHA Study: Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Data Registry and Tissue Repository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faculty of Medicine of Ribeirão Preto (FMRP-USP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>D'Or Institute for Research and Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Americas Medical City: Hospital Samaritano and Hospital Vitória</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Cardiovascular disease remains the leading cause of death in the United States. Mortality&#xD;
      rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially&#xD;
      comatose. Of those who survive, 50% are left with a permanent neurological disability, and&#xD;
      only 10% are able to resume their former lifestyle. Early prognosis of comatose patients&#xD;
      after cardiac arrest is critical for management of these patients, yet predicting outcome for&#xD;
      these patients remains quite challenging.&#xD;
&#xD;
      The primary study objective of MOCHA is to develop an accurate and reliable assessment&#xD;
      algorithm for determining neurologic prognosis in patients initially unconscious (no eye&#xD;
      opening, GCS-M&lt;6 and not following commands) post-cardiac arrest, using multiple prognostic&#xD;
      modalities at standardized time points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a prospective, international, observational study of cardiac&#xD;
      arrest survivors using guideline-recommended prognostic assessment tools with central&#xD;
      adjudication of results, while avoiding premature withdrawal of life-sustaining therapy&#xD;
      (WLST). The investigators will prospectively collect data on demographics, premorbid&#xD;
      characteristics, details of cardiac arrest and resuscitation, post-cardiac arrest care,&#xD;
      detailed neurological examination findings, electrophysiologic studies, chemical biomarkers&#xD;
      and neuroimaging at standardized time points, and will assess functional outcomes at&#xD;
      discharge, 6- and 12-month follow-up, as well as annually up to 5 years. The international&#xD;
      cohort will have a derivation subset that will be used to create a multimodal outcome&#xD;
      prediction model (using regression analysis), which will then be confirmed by the validation&#xD;
      subset. A substudy of MOCHA will also explore the impact of the practice of WLST in the&#xD;
      prediction model by analyzing its performance in a pooled cohort of subjects unexposed to&#xD;
      WLST originating from countries where this practice is not common.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Anticipated">August 2027</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>5 Years</target_duration>
  <primary_outcome>
    <measure>Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC)</measure>
    <time_frame>at 6 months post-arrest</time_frame>
    <description>dichotomized good vs poor outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Score (mRS)</measure>
    <time_frame>at 6 months post-arrest</time_frame>
    <description>dichotomized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Performance Category- Extended (CPC-E)</measure>
    <time_frame>at 6 months post-arrest</time_frame>
    <description>categorical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Test of Adult Cognition by Telephone (BTACT)</measure>
    <time_frame>at 6 months post-arrest</time_frame>
    <description>categorical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MOCA)</measure>
    <time_frame>at 6 months post-arrest</time_frame>
    <description>categorical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 36</measure>
    <time_frame>at 6 months post-arrest</time_frame>
    <description>categorical</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Unresponsive patients post-cardiac arrest</arm_group_label>
    <description>As early as possible post-resuscitation, patients should undergo a detailed neurologic examination, comprised of a thorough assessment for consciousness and detailed cranial nerve function and motor response assessments. Neurologic assessment scores such as the Full Outline of Unresponsiveness, Glasgow Coma Scale (GCS), and Pittsburgh Cardiac Arrest Category Score will be also be used. On the first assessment (day of cardiac arrest), the PCAC score should be assigned only on the basis of the best neurologic exam in the first 6 hours after ROSC. Patients that are sedated or intubated will have the verbal score of GCS be estimated by a derivation of motor and eye scores. The presence of potential confounders, including core body temperature, medications, and/or intoxicants, as well as metabolic derangements should be noted.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Unresponsive patients post-cardiac arrest&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older (no upper age limit)&#xD;
&#xD;
          -  Initially unconscious following cardiac arrest from any non-perfusing rhythm (i.e.,&#xD;
             ventricular tachycardia, ventricular fibrillation, pulseless electrical activity,&#xD;
             asystole)&#xD;
&#xD;
          -  Sustained return of spontaneous circulation (ROSC) as defined by maintained&#xD;
             spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects younger than 18 years of age&#xD;
&#xD;
          -  Isolated respiratory arrest without concomitant or ensuing cardiac arrest&#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>David Greer, MD MA</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Greer, MD MA</last_name>
    <phone>617- 638-5127</phone>
    <email>dgreer@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cathi Thomas</last_name>
    <phone>617- 638-8456</phone>
    <email>neurocat@bu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Greer, MD MA</last_name>
      <phone>617-638-5127</phone>
      <email>dgreer@bu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coma, prognosis, cardiac arrest</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</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/NCT03261089
org study id: H-36257
nct id: NCT03261089
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease remains the leading cause of death in the United States. Mortality
      rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially
      comatose. Of those who survive, 50% are left with a permanent neurological disability, and
      only 10% are able to resume their former lifestyle. Early prognosis of comatose patients
      after cardiac arrest is critical for management of these patients, yet predicting outcome for
      these patients remains quite challenging.

      The primary study objective of MOCHA is to develop an accurate and reliable assessment
      algorithm for determining neurologic prognosis in patients initially unconscious (no eye
      opening, GCS-M<6 and not following commands) post-cardiac arrest, using multiple prognostic
      modalities at standardized time points.
The investigators will conduct a prospective, international, observational study of cardiac
      arrest survivors using guideline-recommended prognostic assessment tools with central
      adjudication of results, while avoiding premature withdrawal of life-sustaining therapy
      (WLST). The investigators will prospectively collect data on demographics, premorbid
      characteristics, details of cardiac arrest and resuscitation, post-cardiac arrest care,
      detailed neurological examination findings, electrophysiologic studies, chemical biomarkers
      and neuroimaging at standardized time points, and will assess functional outcomes at
      discharge, 6- and 12-month follow-up, as well as annually up to 5 years. The international
      cohort will have a derivation subset that will be used to create a multimodal outcome
      prediction model (using regression analysis), which will then be confirmed by the validation
      subset. A substudy of MOCHA will also explore the impact of the practice of WLST in the
      prediction model by analyzing its performance in a pooled cohort of subjects unexposed to
      WLST originating from countries where this practice is not common.
observational model: Cohort
time perspective: Prospective
measure: Glasgow-Pittsburgh Cerebral Performance Category Scale (CPC)
time frame: at 6 months post-arrest
description: dichotomized good vs poor outcome
measure: modified Rankin Score (mRS)
time frame: at 6 months post-arrest
description: dichotomized
measure: Cerebral Performance Category- Extended (CPC-E)
time frame: at 6 months post-arrest
description: categorical
measure: Brief Test of Adult Cognition by Telephone (BTACT)
time frame: at 6 months post-arrest
description: categorical
measure: Montreal Cognitive Assessment (MOCA)
time frame: at 6 months post-arrest
description: categorical
measure: Short Form 36
time frame: at 6 months post-arrest
description: categorical
arm group label: Unresponsive patients post-cardiac arrest
description: As early as possible post-resuscitation, patients should undergo a detailed neurologic examination, comprised of a thorough assessment for consciousness and detailed cranial nerve function and motor response assessments. Neurologic assessment scores such as the Full Outline of Unresponsiveness, Glasgow Coma Scale (GCS), and Pittsburgh Cardiac Arrest Category Score will be also be used. On the first assessment (day of cardiac arrest), the PCAC score should be assigned only on the basis of the best neurologic exam in the first 6 hours after ROSC. Patients that are sedated or intubated will have the verbal score of GCS be estimated by a derivation of motor and eye scores. The presence of potential confounders, including core body temperature, medications, and/or intoxicants, as well as metabolic derangements should be noted.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Greer, MD MA
role: Study Chair
affiliation: Boston Medical Center
last name: David Greer, MD MA
phone: 617- 638-5127
email: dgreer@bu.edu
last name: Cathi Thomas
phone: 617- 638-8456
email: neurocat@bu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: No