<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/NCT04433026</url>
  </required_header>
  <id_info>
    <org_study_id>Cardiac markers in COVID-19</org_study_id>
    <nct_id>NCT04433026</nct_id>
  </id_info>
  <brief_title>BNP, Serum Troponin and D-dimer as Risk Factors in Patients With COVID-19</brief_title>
  <official_title>B-natriuretic Peptide (BNP), Serum Troponin-I, and D-dimer as Risk Factors for In-hospital Death in Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      To evaluate the role of N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and&#xD;
      Troponin - I as risk factors in COVID-19 patients and to correlate these markers with&#xD;
      in-hospital death in patients with COVID-19&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease-2019 (COVID-19), a contagious novel coronavirus now called severe acute&#xD;
      respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV).&#xD;
&#xD;
      Cardiac injury is a common condition among the hospitalized patients with COVID-19. It t was&#xD;
      recently reported that 19.7% patients with COVID-19 had cardiac injury with more adverse&#xD;
      clinical outcomes compared to those without cardiac injury (Shi S, et al, 2020) Fulminant&#xD;
      myocarditis due to direct viral infection can certainly occur, but in patients with increased&#xD;
      oxygen demands due to tachycardia and fever and reduced oxygen delivery due to hypotension&#xD;
      and hypoxemia, COVID 19 disease can cause myocardial injury indirectly. Cytokines released&#xD;
      during the acute infection can elicit activation of cells within pre-existing atherosclerotic&#xD;
      lesions, augmenting thrombotic risk and risk of ischemic syndromes. Moreover, microvascular&#xD;
      activation by cytokines can cause not only myocardial injury but can also harm other organ&#xD;
      systems commonly involved in COVID-19 infections including the kidneys.(Peter,2020) Treatment&#xD;
      in intensive care units (ICU) has become a major challenge; therefore, early recognition of&#xD;
      severe forms is absolutely essential for timely triaging of patients. Several laboratory&#xD;
      parameters may facilitate the assessment of disease severity. The recognized risk factors&#xD;
      such as old age and underlying comorbidities-particularly cardiovascular diseases, diabetes,&#xD;
      respiratory diseases, and other conditions (Zhou et al,2020) Several markers have been&#xD;
      identified that modulate the course of COVID-19. The heart failure marker, N terminal pro B&#xD;
      type natriuretic peptide (NT-proBNP), increased significantly during the course of&#xD;
      hospitalization (Guo T, et al ,2020) The sensitivity of cardiac troponin testing that ensures&#xD;
      it is one of the earliest and most precise indicators of end organ dysfunction. Cardiac&#xD;
      troponin testing could prompt early initiation of measures to improve tissue oxygenation and&#xD;
      perfusion.&#xD;
&#xD;
      COVID-19 infection is associated with intra-alveolar fibrin deposition, leading to lethal&#xD;
      respiratory failure; reports suggesting that anticoagulation or fibrinolytic therapy can&#xD;
      improve clinical outcomes (Wang J, et Al , 2020) ; case series implying that large&#xD;
      percentages of severely affected COVID-19 patients suffer clinically significant thrombosis&#xD;
      (Porfidia A , et al ,2020)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>
  <primary_outcome>
    <measure>Measurement of N-terminal pro-B type natriuretic peptide, troponin-I and D-dimer in COVID-19 patients</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of the level of these markers in COVID-19 patients and collerate these measurements with early signs of cardiac injury in COVID-19 patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac complications in COVID-19 patients associated with more adverse effects</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of the level of N-terminal pro-B type natriuretic peptide, Troponin-I and D-dimer may help in detection of early signs of cardiac injury which in turn may help to minimize the risk of in-hospital deaths in COVID-19 patients</description>
  </primary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I</intervention_name>
    <description>Biomarkers detected in the serum of patients</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study initially enrolled 90 patients with COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with COVID-19 (moderate and severe cases) Different age groups&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had stroke and acute myocardial infarction, malignant tumor, and&#xD;
             pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Areej Saleh</last_name>
    <phone>+201007728031</phone>
    <email>areej.20123824@med.aun.edu</email>
  </overall_contact>
  <reference>
    <citation>Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.</citation>
    <PMID>32211816</PMID>
  </reference>
  <reference>
    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </reference>
  <reference>
    <citation>Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017. Erratum In: JAMA Cardiol. 2020 Jul 1;5(7):848.</citation>
    <PMID>32219356</PMID>
  </reference>
  <reference>
    <citation>Libby P. The Heart in COVID-19: Primary Target or Secondary Bystander? JACC Basic Transl Sci. 2020 Apr 10;5(5):537-542. doi: 10.1016/j.jacbts.2020.04.001. eCollection 2020 May.</citation>
    <PMID>32292847</PMID>
  </reference>
  <reference>
    <citation>Wang J, Hajizadeh N, Moore EE, McIntyre RC, Moore PK, Veress LA, Yaffe MB, Moore HB, Barrett CD. Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): A case series. J Thromb Haemost. 2020 Jul;18(7):1752-1755. doi: 10.1111/jth.14828. Epub 2020 May 11.</citation>
    <PMID>32267998</PMID>
  </reference>
  <reference>
    <citation>Porfidia A, Pola R. Venous thromboembolism in COVID-19 patients. J Thromb Haemost. 2020 Jun;18(6):1516-1517. doi: 10.1111/jth.14842. No abstract available.</citation>
    <PMID>32294289</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 20, 2020</last_update_submitted>
  <last_update_submitted_qc>August 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Areej Osama Ali Mohammed Saleh</investigator_full_name>
    <investigator_title>Resident physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Natriuretic Peptide, Brain</mesh_term>
  </intervention_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/NCT04433026
org study id: Cardiac markers in COVID-19
nct id: NCT04433026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the role of N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and
      Troponin - I as risk factors in COVID-19 patients and to correlate these markers with
      in-hospital death in patients with COVID-19
Coronavirus disease-2019 (COVID-19), a contagious novel coronavirus now called severe acute
      respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV).

      Cardiac injury is a common condition among the hospitalized patients with COVID-19. It t was
      recently reported that 19.7% patients with COVID-19 had cardiac injury with more adverse
      clinical outcomes compared to those without cardiac injury (Shi S, et al, 2020) Fulminant
      myocarditis due to direct viral infection can certainly occur, but in patients with increased
      oxygen demands due to tachycardia and fever and reduced oxygen delivery due to hypotension
      and hypoxemia, COVID 19 disease can cause myocardial injury indirectly. Cytokines released
      during the acute infection can elicit activation of cells within pre-existing atherosclerotic
      lesions, augmenting thrombotic risk and risk of ischemic syndromes. Moreover, microvascular
      activation by cytokines can cause not only myocardial injury but can also harm other organ
      systems commonly involved in COVID-19 infections including the kidneys.(Peter,2020) Treatment
      in intensive care units (ICU) has become a major challenge; therefore, early recognition of
      severe forms is absolutely essential for timely triaging of patients. Several laboratory
      parameters may facilitate the assessment of disease severity. The recognized risk factors
      such as old age and underlying comorbidities-particularly cardiovascular diseases, diabetes,
      respiratory diseases, and other conditions (Zhou et al,2020) Several markers have been
      identified that modulate the course of COVID-19. The heart failure marker, N terminal pro B
      type natriuretic peptide (NT-proBNP), increased significantly during the course of
      hospitalization (Guo T, et al ,2020) The sensitivity of cardiac troponin testing that ensures
      it is one of the earliest and most precise indicators of end organ dysfunction. Cardiac
      troponin testing could prompt early initiation of measures to improve tissue oxygenation and
      perfusion.

      COVID-19 infection is associated with intra-alveolar fibrin deposition, leading to lethal
      respiratory failure; reports suggesting that anticoagulation or fibrinolytic therapy can
      improve clinical outcomes (Wang J, et Al , 2020) ; case series implying that large
      percentages of severely affected COVID-19 patients suffer clinically significant thrombosis
      (Porfidia A , et al ,2020)
observational model: Case-Only
time perspective: Retrospective
measure: Measurement of N-terminal pro-B type natriuretic peptide, troponin-I and D-dimer in COVID-19 patients
time frame: Baseline
description: Measurement of the level of these markers in COVID-19 patients and collerate these measurements with early signs of cardiac injury in COVID-19 patients
measure: Cardiac complications in COVID-19 patients associated with more adverse effects
time frame: Baseline
description: Measurement of the level of N-terminal pro-B type natriuretic peptide, Troponin-I and D-dimer may help in detection of early signs of cardiac injury which in turn may help to minimize the risk of in-hospital deaths in COVID-19 patients
intervention type: Diagnostic Test
intervention name: N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I
description: Biomarkers detected in the serum of patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Areej Saleh
phone: +201007728031
email: areej.20123824@med.aun.edu
citation: Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
PMID: 32211816
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
citation: Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017. Erratum In: JAMA Cardiol. 2020 Jul 1;5(7):848.
PMID: 32219356
citation: Libby P. The Heart in COVID-19: Primary Target or Secondary Bystander? JACC Basic Transl Sci. 2020 Apr 10;5(5):537-542. doi: 10.1016/j.jacbts.2020.04.001. eCollection 2020 May.
PMID: 32292847
citation: Wang J, Hajizadeh N, Moore EE, McIntyre RC, Moore PK, Veress LA, Yaffe MB, Moore HB, Barrett CD. Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): A case series. J Thromb Haemost. 2020 Jul;18(7):1752-1755. doi: 10.1111/jth.14828. Epub 2020 May 11.
PMID: 32267998
citation: Porfidia A, Pola R. Venous thromboembolism in COVID-19 patients. J Thromb Haemost. 2020 Jun;18(6):1516-1517. doi: 10.1111/jth.14842. No abstract available.
PMID: 32294289
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Areej Osama Ali Mohammed Saleh
investigator title: Resident physician
mesh term: COVID-19
mesh term: Natriuretic Peptide, Brain