<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/NCT03801694</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0436</org_study_id>
    <nct_id>NCT03801694</nct_id>
  </id_info>
  <brief_title>Predicting the Development of Myocardial Depression in Acute Neurological Patients</brief_title>
  <official_title>To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State 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 purpose of this study is to assess the levels of serum catecholamines associated with&#xD;
      myocardial depression (MD) in patients with acute neurological injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the level of plasma catecholamines, associated&#xD;
      with myocardial depression (MD) as noted on Transthoracic ECHO (TTE) by evidence of wall&#xD;
      motion abnormalities (WMA) with or without drop in ejection fraction or symptomatic heart&#xD;
      failure (HF). Takotsubo syndrome (TTS) is commonly diagnosed after the onset of HF once&#xD;
      patients become symptomatic. The investigators intend to study whether early MD can be&#xD;
      detected by identifying certain levels of plasma catecholamines and whether the level&#xD;
      correlates with severity of myocardial depression. Identification of early MD changes can&#xD;
      lead to alteration of management strategies and may help prevent worsening of HF. Highly&#xD;
      selected patients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS) requiring&#xD;
      induced hypertension with the use of norepinephrine infusion will be recruited to enroll in&#xD;
      this pilot study. This group of patients are expected to have high circulating catecholamines&#xD;
      and are more likely to develop MD. Given the prevalence of TTS in females and elderly, 10&#xD;
      female patients &gt;50 years admitted to the neuro ICU with diagnosis of either AIS or SAH will&#xD;
      be enrolled. Patients with history of coronary artery disease, smoking, poorly controlled&#xD;
      diabetes with HbA1c &gt;8 and uncontrolled hypertension will be excluded. Patients with poor&#xD;
      ECHO windows will also be excluded. Baseline plasma catecholamine levels, transthoracic&#xD;
      ECHO(TTE), Troponin T, EKG and BNP will be obtained and will be followed daily through the&#xD;
      study duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Association of plasma catecholamine levels with stress induced cardiomyopathy</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Baseline plasma catecholamine levels as well as daily levels will be measured until up to 5 days from study onset. Baseline transthoracic ECHO followed by daily ECHO with strain imaging will be obtained to assess for evidence of myocardial depression. The investigators will assess the correlation of plasma catecholamine levels (i.e level of dopamine, epinephrine and norepinephrine) in the development of myocardial depression. In other words, the investigators will evaluate the level of catecholamines that is associated with stress induced cardiomyopathy. If participants develop symptomatic heart failure before 5 days, study will stop at that point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association of troponin levels with stress induced cardiomyopathy</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Baseline troponin level will be measured as well as daily levels will be obtained for 5 days. The investigators will study the correlation of troponin levels with the myocardial depression noted on ECHO.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association of ST-T changes on EKG with stress induced cardiomyopathy</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Baseline EKG and daily EKG measurements will be taken. These will be examined for ST-T wave changes in participants with evidence of myocardial depression on ECHO.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Myocardial Depression</condition>
  <condition>Takotsubo Syndrome</condition>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Acute Ischemic Stroke</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Baseline plasma catecholamine levels, transthoracic ECHO(TTE), Troponin T, EKG and BNP will&#xD;
      be obtained. Thereafter, we will follow daily plasma catecholamine levels, troponin, EKG and&#xD;
      BNP up to 5 days from the study onset&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Highly selected partients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS)&#xD;
        requiring induced hypertension with the use of norepinephrine infusion will be involve in&#xD;
        this pilot study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients &gt;50 years admitted to the neuro ICU with diagnosis of either acute&#xD;
             ischemic stroke or subarachnoid hemorrhage&#xD;
&#xD;
          -  Only patients predicted to be on norepinephrine infusion for at least 48 hrs will be&#xD;
             selected.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with known history of heart failure will be excluded&#xD;
&#xD;
          -  Patients with history of coronary artery disease, smoking, poorly controlled diabetes&#xD;
             with HbA1c &gt;8 and uncontrolled hypertension will be excluded.&#xD;
&#xD;
          -  Patients with poor ECHO windows will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female patients &gt;50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamara Strohm</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tamara Strohm, MD</last_name>
    <phone>6146888933</phone>
    <email>tamara.strohm@osumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erica Bell, PhD</last_name>
    <phone>614.293.3019</phone>
    <email>erica.bell@osumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ohio Sate University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shradda Mainali, MD</last_name>
      <phone>614-293-9274</phone>
      <email>shradda.mainali@osumc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Carson Reider, PhD</last_name>
      <phone>614.293.9274</phone>
      <email>Carson.Reider@osumc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Tamara Strohm</investigator_full_name>
    <investigator_title>Assistant Professor- Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Takotsubo Cardiomyopathy</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT03801694
org study id: 2018H0436
nct id: NCT03801694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the levels of serum catecholamines associated with
      myocardial depression (MD) in patients with acute neurological injury.
The purpose of this study is to investigate the level of plasma catecholamines, associated
      with myocardial depression (MD) as noted on Transthoracic ECHO (TTE) by evidence of wall
      motion abnormalities (WMA) with or without drop in ejection fraction or symptomatic heart
      failure (HF). Takotsubo syndrome (TTS) is commonly diagnosed after the onset of HF once
      patients become symptomatic. The investigators intend to study whether early MD can be
      detected by identifying certain levels of plasma catecholamines and whether the level
      correlates with severity of myocardial depression. Identification of early MD changes can
      lead to alteration of management strategies and may help prevent worsening of HF. Highly
      selected patients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS) requiring
      induced hypertension with the use of norepinephrine infusion will be recruited to enroll in
      this pilot study. This group of patients are expected to have high circulating catecholamines
      and are more likely to develop MD. Given the prevalence of TTS in females and elderly, 10
      female patients >50 years admitted to the neuro ICU with diagnosis of either AIS or SAH will
      be enrolled. Patients with history of coronary artery disease, smoking, poorly controlled
      diabetes with HbA1c >8 and uncontrolled hypertension will be excluded. Patients with poor
      ECHO windows will also be excluded. Baseline plasma catecholamine levels, transthoracic
      ECHO(TTE), Troponin T, EKG and BNP will be obtained and will be followed daily through the
      study duration.
observational model: Cohort
time perspective: Prospective
measure: Association of plasma catecholamine levels with stress induced cardiomyopathy
time frame: up to 5 days
description: Baseline plasma catecholamine levels as well as daily levels will be measured until up to 5 days from study onset. Baseline transthoracic ECHO followed by daily ECHO with strain imaging will be obtained to assess for evidence of myocardial depression. The investigators will assess the correlation of plasma catecholamine levels (i.e level of dopamine, epinephrine and norepinephrine) in the development of myocardial depression. In other words, the investigators will evaluate the level of catecholamines that is associated with stress induced cardiomyopathy. If participants develop symptomatic heart failure before 5 days, study will stop at that point.
measure: Association of troponin levels with stress induced cardiomyopathy
time frame: up to 5 days
description: Baseline troponin level will be measured as well as daily levels will be obtained for 5 days. The investigators will study the correlation of troponin levels with the myocardial depression noted on ECHO.
measure: Association of ST-T changes on EKG with stress induced cardiomyopathy
time frame: up to 5 days
description: Baseline EKG and daily EKG measurements will be taken. These will be examined for ST-T wave changes in participants with evidence of myocardial depression on ECHO.
Baseline plasma catecholamine levels, transthoracic ECHO(TTE), Troponin T, EKG and BNP will
      be obtained. Thereafter, we will follow daily plasma catecholamine levels, troponin, EKG and
      BNP up to 5 days from the study onset
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female patients >50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Tamara Strohm
role: Principal Investigator
affiliation: Ohio State University
last name: Tamara Strohm, MD
phone: 6146888933
email: tamara.strohm@osumc.edu
last name: Erica Bell, PhD
phone: 614.293.3019
email: erica.bell@osumc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Tamara Strohm
investigator title: Assistant Professor- Neurology
mesh term: Ischemic Stroke
mesh term: Subarachnoid Hemorrhage
mesh term: Takotsubo Cardiomyopathy
mesh term: Hemorrhage
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No