<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/NCT01706068</url>
  </required_header>
  <id_info>
    <org_study_id>ECGCTIL</org_study_id>
    <nct_id>NCT01706068</nct_id>
  </id_info>
  <brief_title>Transient ECG Changes in Patients With Acute Biliary Disease</brief_title>
  <official_title>Transient ECG Changes in Patients With Acute Biliary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The importance of ischemic ECG changes including St segment elevation, ST segment depression&#xD;
      or T wave inversion that indicate myocardial ischemia are well established and require&#xD;
      appropriate investigation and treatment.&#xD;
&#xD;
      However, there is an abundance of clinical situation, with apparently ischemic ECG change not&#xD;
      indicate traditionally coronary artery related ischemia and therefore require prompt&#xD;
      recognition and treatment of underlying condition, that may be serious and life-threatened.&#xD;
      For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte&#xD;
      abnormalities, intracranial hemorrhage and hypothermia.&#xD;
&#xD;
      Together with them, an ECG ST segment changes may appeared in abdominal serious illness such&#xD;
      as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive&#xD;
      and toxic for myocardium substances released, the cause of ST segment changes in&#xD;
      cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma&#xD;
      rennin activity resulted by distension of the gallbladder.&#xD;
&#xD;
      The certain proportion of the patients with ECG changes actually didn't have coronary artery&#xD;
      disease(9,15) or other acute cardiac condition and therefore require treatment of the&#xD;
      underlie illness only without spend the time for cardiac investigation or special&#xD;
      treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with&#xD;
      abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or&#xD;
      unnecessary cardiac catheterization.&#xD;
&#xD;
      In the medical literature the investigators found some case reports and works about the ECG&#xD;
      changes in acute biliary disease in patient with knowing cardiac disease and without it, but&#xD;
      actually incidence of ECG changes that suggest but not represent an acute coronary illness&#xD;
      isn't knowing.&#xD;
&#xD;
      Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute&#xD;
      coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical&#xD;
      and laboratory characteristics that helps to differentiate this patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Cholecystitis</condition>
  <condition>Biliary Colic</condition>
  <condition>Acute Cholangitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ECG changes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients from age 18 and up to 75years old.&#xD;
&#xD;
          2. Causes of admission to the ED are acute cholecystitis, biliary colic, acute&#xD;
             cholangitis&#xD;
&#xD;
          3. The patient is willing to participate in the study and is able to sign an informed&#xD;
             consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Elective hospitalization with known and not acute condition.&#xD;
&#xD;
          2. Inability to give inform consent .&#xD;
&#xD;
          3. Sepsis as complication of illness.&#xD;
&#xD;
          4. Chronic ECG changes known by medical history.&#xD;
&#xD;
          5. Knowing history of IHD.&#xD;
&#xD;
          6. Previous cardiac catheterization with documented stenosis of at least 1 major coronary&#xD;
             artery equal or more 50%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ziv Medical Center</name>
      <address>
        <city>Zefat</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Inna Rozenfeld, MD</last_name>
      <phone>972508434217</phone>
      <email>innacardros@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Inna Rozenfeld, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziv Hospital</investigator_affiliation>
    <investigator_full_name>Inna Rozenfeld , MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>acute ECG changes</keyword>
  <keyword>acute illness of gallbladder</keyword>
  <keyword>acute illness of biliary tract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</mesh_term>
    <mesh_term>Gallbladder Diseases</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/NCT01706068
org study id: ECGCTIL
nct id: NCT01706068
lead sponsor: 
has dmc: Yes
Background:

      The importance of ischemic ECG changes including St segment elevation, ST segment depression
      or T wave inversion that indicate myocardial ischemia are well established and require
      appropriate investigation and treatment.

      However, there is an abundance of clinical situation, with apparently ischemic ECG change not
      indicate traditionally coronary artery related ischemia and therefore require prompt
      recognition and treatment of underlying condition, that may be serious and life-threatened.
      For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte
      abnormalities, intracranial hemorrhage and hypothermia.

      Together with them, an ECG ST segment changes may appeared in abdominal serious illness such
      as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive
      and toxic for myocardium substances released, the cause of ST segment changes in
      cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma
      rennin activity resulted by distension of the gallbladder.

      The certain proportion of the patients with ECG changes actually didn't have coronary artery
      disease(9,15) or other acute cardiac condition and therefore require treatment of the
      underlie illness only without spend the time for cardiac investigation or special
      treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with
      abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or
      unnecessary cardiac catheterization.

      In the medical literature the investigators found some case reports and works about the ECG
      changes in acute biliary disease in patient with knowing cardiac disease and without it, but
      actually incidence of ECG changes that suggest but not represent an acute coronary illness
      isn't knowing.

      Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute
      coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical
      and laboratory characteristics that helps to differentiate this patients.
observational model: Case-Only
time perspective: Retrospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Ziv Hospital
investigator full name: Inna Rozenfeld , MD
investigator title: Principal Investigator
mesh term: Cholangitis
mesh term: Cholecystitis
mesh term: Cholecystitis, Acute
mesh term: Gallbladder Diseases