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/NCT05985720</url>
    </required_header>
    <id_info>
      <org_study_id>Asthmatic children</org_study_id>
      <nct_id>NCT05985720</nct_id>
    </id_info>
    <brief_title>Evaluation of Cardiac Biomarkers and Ventricular Function in Asthmatic Children</brief_title>
    <official_title>Evaluation of Cardiac Biomarkers and the Left and Right Ventricular Systolic and Diastolic Function in Asthmatic Children in Assuit University Hospital</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>
        Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic&#xD;
        function in asthmatic children in Assuit university hospital&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Severe acute asthma which is defined asthma that is uncontrolled despite maximal optimized&#xD;
        therapy and treatment of contributory factors, or that worsens when high dose treatment is&#xD;
        decreased(1) and it is characterized by severe respiratory distress because of increasing&#xD;
        bronchoconstriction, leading to ventilation perfusion mismatch, hypoxia, respiratory muscle&#xD;
        fatigue, carbon dioxide retention and respiratory acidosis(2) In acute severe asthma, the use&#xD;
        of beta 2 agonists, together with hypoxia and tachycardia might cause increased myocardial&#xD;
        workload further leading to myocardial infarction(3).&#xD;
  &#xD;
        Cardiac biomarkers including Brain Natriuretic Peptide (BNP),Troponin I (TnI) and Creatine&#xD;
        kinase muscle/brain(CK-MB) are used to detect myocardial injury(4).&#xD;
  &#xD;
        The objective of the present study was to find out the incidence of myocardial dysfunction in&#xD;
        patients of acute severe bronchial asthma based on cardiac biomarker levels at admission and&#xD;
        to see whether the myocardial dysfunction was transient or persistent even after the&#xD;
        stabilization of the patient. As far as it could be reviewed, no study relating BNP levels in&#xD;
        pediatric asthma patients could be found in literature.&#xD;
  &#xD;
        Echocardiographic changes in bronchial asthma regarding RT ventricular and Ltventricular&#xD;
        function will be assessed According to some studies right ventricular (RV) systolic and&#xD;
        diastolic dysfunction were detected, even in mild cases, by echocardiography. On the other&#xD;
        hand, left ventricular (LV) dysfunction usually presents itself in severe asthmatic cases&#xD;
        which may be reversible in acute conditions (5).&#xD;
  &#xD;
        Some studies showed that there were no differences in echocardiographic findings regarding&#xD;
        the ventricular function with the exception of RV wall thickness (6).&#xD;
  &#xD;
        Asthma affects ventricular contractility in children. Although cardiac systolic function was&#xD;
        found to be impaired in asthmatic patients, contrary to the literature diastolic dysfunction&#xD;
        didn't observed in these patients even by tissue Doppler imaging, may be due to using inhaled&#xD;
        corticosteroid(7). This was one of the most comprehensive studies among asthmatic patients.&#xD;
        Further studies with larger sample sizes or without using corticosteroid treatment war ranted&#xD;
        to better elucidate the cardiac function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>to identify the relation between asthmatic children and cardiac function</measure>
      <time_frame>Baseline</time_frame>
      <description>relation between asthma and cardiac function</description>
    </primary_outcome>
    <primary_outcome>
      <measure>to identify the relation between asthmatic children and myocardial dysfunction</measure>
      <time_frame>Baseline</time_frame>
      <description>relation between asthma and myocardial dysfunction</description>
    </primary_outcome>
    <other_outcome>
      <measure>to identify the relation between asthmatic children and child weight</measure>
      <time_frame>Baseline</time_frame>
      <description>relation between asthma outcome and patient wieght</description>
    </other_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Ventricular Dysfunction</condition>
    <condition>Asthma in Children</condition>
    <eligibility>
      <study_pop>
        <textblock>
          children aged from 5 years to 15 years diagnosed as bronchial asthma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all pediatric cases between the age of 5 -15years with acute severe bronchial asthma&#xD;
               who were admitted in pediatric emergency care unit&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with congenital or acquired heart diseases&#xD;
  &#xD;
            -  Foreign body aspiration .&#xD;
  &#xD;
            -  Chest infections&#xD;
  &#xD;
            -  Tuberculosis or pneumonia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <reference>
      <citation>Rodriguez-Roisin R, Ballester E, Roca J, Torres A, Wagner PD. Mechanisms of hypoxemia in patients with status asthmaticus requiring mechanical ventilation. Am Rev Respir Dis. 1989 Mar;139(3):732-9. doi: 10.1164/ajrccm/139.3.732.</citation>
      <PMID>2923373</PMID>
    </reference>
    <reference>
      <citation>Peng SM, Sun P, Zeng J, Deng XM. [Cardiac function of children with bronchial asthma]. Zhongguo Dang Dai Er Ke Za Zhi. 2006 Oct;8(5):388-90. Chinese.</citation>
      <PMID>17052399</PMID>
    </reference>
    <reference>
      <citation>Zeybek C, Yalcin Y, Erdem A, Polat TB, Aktuglu-Zeybek AC, Bayoglu V, Akdeniz C, Celebi A. Tissue Doppler echocardiographic assessment of cardiac function in children with bronchial asthma. Pediatr Int. 2007 Dec;49(6):911-7. doi: 10.1111/j.1442-200X.2007.02486.x.</citation>
      <PMID>18045296</PMID>
    </reference>
    <reference>
      <citation>Shedeed SA. Right ventricular function in children with bronchial asthma: a tissue Doppler echocardiographic study. Pediatr Cardiol. 2010 Oct;31(7):1008-15. doi: 10.1007/s00246-010-9753-2. Epub 2010 Aug 10.</citation>
      <PMID>20697704</PMID>
    </reference>
    <reference>
      <citation>Sears MR. Trends in the prevalence of asthma. Chest. 2014 Feb;145(2):219-225. doi: 10.1378/chest.13-2059.</citation>
      <PMID>24493506</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Asmaa Khalaf Saber</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>asthma</keyword>
    <keyword>cardiac affection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ventricular Dysfunction</mesh_term>
    </condition_browse>
    <!-- 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/NCT05985720
  org study id: Asthmatic children
  nct id: NCT05985720
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic
        function in asthmatic children in Assuit university hospital
  Severe acute asthma which is defined asthma that is uncontrolled despite maximal optimized
        therapy and treatment of contributory factors, or that worsens when high dose treatment is
        decreased(1) and it is characterized by severe respiratory distress because of increasing
        bronchoconstriction, leading to ventilation perfusion mismatch, hypoxia, respiratory muscle
        fatigue, carbon dioxide retention and respiratory acidosis(2) In acute severe asthma, the use
        of beta 2 agonists, together with hypoxia and tachycardia might cause increased myocardial
        workload further leading to myocardial infarction(3).
  
        Cardiac biomarkers including Brain Natriuretic Peptide (BNP),Troponin I (TnI) and Creatine
        kinase muscle/brain(CK-MB) are used to detect myocardial injury(4).
  
        The objective of the present study was to find out the incidence of myocardial dysfunction in
        patients of acute severe bronchial asthma based on cardiac biomarker levels at admission and
        to see whether the myocardial dysfunction was transient or persistent even after the
        stabilization of the patient. As far as it could be reviewed, no study relating BNP levels in
        pediatric asthma patients could be found in literature.
  
        Echocardiographic changes in bronchial asthma regarding RT ventricular and Ltventricular
        function will be assessed According to some studies right ventricular (RV) systolic and
        diastolic dysfunction were detected, even in mild cases, by echocardiography. On the other
        hand, left ventricular (LV) dysfunction usually presents itself in severe asthmatic cases
        which may be reversible in acute conditions (5).
  
        Some studies showed that there were no differences in echocardiographic findings regarding
        the ventricular function with the exception of RV wall thickness (6).
  
        Asthma affects ventricular contractility in children. Although cardiac systolic function was
        found to be impaired in asthmatic patients, contrary to the literature diastolic dysfunction
        didn't observed in these patients even by tissue Doppler imaging, may be due to using inhaled
        corticosteroid(7). This was one of the most comprehensive studies among asthmatic patients.
        Further studies with larger sample sizes or without using corticosteroid treatment war ranted
        to better elucidate the cardiac function.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: to identify the relation between asthmatic children and cardiac function
  time frame: Baseline
  description: relation between asthma and cardiac function
  measure: to identify the relation between asthmatic children and myocardial dysfunction
  time frame: Baseline
  description: relation between asthma and myocardial dysfunction
  measure: to identify the relation between asthmatic children and child weight
  time frame: Baseline
  description: relation between asthma outcome and patient wieght
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 15 Years
  healthy volunteers: No
  citation: Rodriguez-Roisin R, Ballester E, Roca J, Torres A, Wagner PD. Mechanisms of hypoxemia in patients with status asthmaticus requiring mechanical ventilation. Am Rev Respir Dis. 1989 Mar;139(3):732-9. doi: 10.1164/ajrccm/139.3.732.
  PMID: 2923373
  citation: Peng SM, Sun P, Zeng J, Deng XM. [Cardiac function of children with bronchial asthma]. Zhongguo Dang Dai Er Ke Za Zhi. 2006 Oct;8(5):388-90. Chinese.
  PMID: 17052399
  citation: Zeybek C, Yalcin Y, Erdem A, Polat TB, Aktuglu-Zeybek AC, Bayoglu V, Akdeniz C, Celebi A. Tissue Doppler echocardiographic assessment of cardiac function in children with bronchial asthma. Pediatr Int. 2007 Dec;49(6):911-7. doi: 10.1111/j.1442-200X.2007.02486.x.
  PMID: 18045296
  citation: Shedeed SA. Right ventricular function in children with bronchial asthma: a tissue Doppler echocardiographic study. Pediatr Cardiol. 2010 Oct;31(7):1008-15. doi: 10.1007/s00246-010-9753-2. Epub 2010 Aug 10.
  PMID: 20697704
  citation: Sears MR. Trends in the prevalence of asthma. Chest. 2014 Feb;145(2):219-225. doi: 10.1378/chest.13-2059.
  PMID: 24493506
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Asmaa Khalaf Saber
  investigator title: Principal Investigator
  mesh term: Ventricular Dysfunction