<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/NCT03253315</url>
  </required_header>
  <id_info>
    <org_study_id>ayafadl24791</org_study_id>
    <nct_id>NCT03253315</nct_id>
  </id_info>
  <brief_title>Management of Pericarditis in Children.</brief_title>
  <official_title>Clinical Audit of the Management of Pericarditis in Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pericardium is a double-walled sac containing the heart and the roots of the great&#xD;
      vessels. The pericardial sac has two layers, a serous visceral l layer (also known as&#xD;
      epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It&#xD;
      encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the&#xD;
      heart to the mediastinum, gives protection against infection and provides lubrication for the&#xD;
      heart. Pericardial diseases may be either isolated disease or part of a systemic disease&#xD;
      Diseases of the pericardium present clinically in one of several ways&#xD;
&#xD;
        -  Acute and recurrent pericarditis&#xD;
&#xD;
        -  Pericardial effusion without major hemodynamic compromise&#xD;
&#xD;
        -  Cardiac tamponade with cardiac compromise&#xD;
&#xD;
        -  Constrictive pericarditis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Pericarditis usually present with chest pain and dyspnea. Effusion can present with no&#xD;
           symptoms, dull ache in left chest and abdominal pain Cardiac tamponade is recognized by&#xD;
           the excessive fall of systolic blood pressure&#xD;
&#xD;
        -  Diagnostic workup A) Chest X-ray:_ chest X-ray can detect varying degree of&#xD;
           cardiomegaly. B) Echocardiography: It is the first-line imaging test. clinically,&#xD;
           two-dimensional echocardiography with Doppler provides the most cost-effective way of&#xD;
           diagnosing C) Electrocardiograph D) cardiac computerized tomography :- Also may be&#xD;
           helpful 4)Therapy of pericarditis in pediatrics the medical lines of treatment of&#xD;
           pericarditis are:_ A)Aspirin and non-steroidal anti-inflammatory:_ are the mainstay of&#xD;
           the therapy of inflammatory pericardial diseases B)Steroids: a minority of patients will&#xD;
           require treatment with systemic steroid therapy as&#xD;
&#xD;
             -  Patients with symptoms refractory to standard therapy&#xD;
&#xD;
                  -  Acute pericarditis due to connective tissue disease ●Uremic pericarditis&#xD;
                     C)Immunosuppressant and biological drugs (more commonly used in recurrent&#xD;
                     pericarditis) .Interventional therapeutic techniques-_&#xD;
&#xD;
      Most patients with acute pericarditis can be managed effectively with medical therapy alone.&#xD;
      However, patients may require invasive therapies for:&#xD;
&#xD;
        -  A moderate to large pericardial effusion, particularly if hemodynamically significant.&#xD;
&#xD;
        -  Frequent, highly symptomatic recurrences of acute pericarditis with pericardial effusion&#xD;
           ●Evidence of constrictive pericarditis (a late occurrence when present) A)Pericardial&#xD;
           drainage :Prolonged catheter drainage of a pericardial effusion is an effective means of&#xD;
           preventing fluid reaccumulation.&#xD;
&#xD;
      B)Pericardiotomy, pericardial window and pericardiectomy: pericardiectomy may be considered&#xD;
      for frequent and highly symptomatic recurrences of pericarditis tamponade .. C)Surgical&#xD;
      decompression of the pericardium :_can be achieved either by conventional heart surgery or&#xD;
      video-assisted thoracoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>15 Days</target_duration>
  <primary_outcome>
    <measure>Echocardiographic signs</measure>
    <time_frame>one month</time_frame>
    <description>normal cardiac size by echocardiography (measurable by echocardiographic probe)&#xD;
normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pericarditis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients who above one year of age up to 18 years diagnosed with pericarditis and/or&#xD;
        pericardial effusions are candidates for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with pericarditis and/or pericardial effusion above one year of age detected&#xD;
             clinically and by echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children below one year of age. - children with malignant effusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>nagwa ali, MD</last_name>
      <phone>01096260950</phone>
      <email>namma65@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>aya gomaa mohamed</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pericarditis</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/NCT03253315
org study id: ayafadl24791
nct id: NCT03253315
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The pericardium is a double-walled sac containing the heart and the roots of the great
      vessels. The pericardial sac has two layers, a serous visceral l layer (also known as
      epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It
      encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the
      heart to the mediastinum, gives protection against infection and provides lubrication for the
      heart. Pericardial diseases may be either isolated disease or part of a systemic disease
      Diseases of the pericardium present clinically in one of several ways

        -  Acute and recurrent pericarditis

        -  Pericardial effusion without major hemodynamic compromise

        -  Cardiac tamponade with cardiac compromise

        -  Constrictive pericarditis
-  Pericarditis usually present with chest pain and dyspnea. Effusion can present with no
           symptoms, dull ache in left chest and abdominal pain Cardiac tamponade is recognized by
           the excessive fall of systolic blood pressure

        -  Diagnostic workup A) Chest X-ray:_ chest X-ray can detect varying degree of
           cardiomegaly. B) Echocardiography: It is the first-line imaging test. clinically,
           two-dimensional echocardiography with Doppler provides the most cost-effective way of
           diagnosing C) Electrocardiograph D) cardiac computerized tomography :- Also may be
           helpful 4)Therapy of pericarditis in pediatrics the medical lines of treatment of
           pericarditis are:_ A)Aspirin and non-steroidal anti-inflammatory:_ are the mainstay of
           the therapy of inflammatory pericardial diseases B)Steroids: a minority of patients will
           require treatment with systemic steroid therapy as

             -  Patients with symptoms refractory to standard therapy

                  -  Acute pericarditis due to connective tissue disease ●Uremic pericarditis
                     C)Immunosuppressant and biological drugs (more commonly used in recurrent
                     pericarditis) .Interventional therapeutic techniques-_

      Most patients with acute pericarditis can be managed effectively with medical therapy alone.
      However, patients may require invasive therapies for:

        -  A moderate to large pericardial effusion, particularly if hemodynamically significant.

        -  Frequent, highly symptomatic recurrences of acute pericarditis with pericardial effusion
           ●Evidence of constrictive pericarditis (a late occurrence when present) A)Pericardial
           drainage :Prolonged catheter drainage of a pericardial effusion is an effective means of
           preventing fluid reaccumulation.

      B)Pericardiotomy, pericardial window and pericardiectomy: pericardiectomy may be considered
      for frequent and highly symptomatic recurrences of pericarditis tamponade .. C)Surgical
      decompression of the pericardium :_can be achieved either by conventional heart surgery or
      video-assisted thoracoscopy.
observational model: Other
time perspective: Other
measure: Echocardiographic signs
time frame: one month
description: normal cardiac size by echocardiography (measurable by echocardiographic probe)
normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Years
healthy volunteers: No
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: aya gomaa mohamed
investigator title: Principal investigator
mesh term: Pericarditis