<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/NCT03831204</url>
  </required_header>
  <id_info>
    <org_study_id>STI in AHF prognostic</org_study_id>
    <nct_id>NCT03831204</nct_id>
  </id_info>
  <brief_title>Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)</brief_title>
  <official_title>Systolic Time Intervals a Pronostic Tool of Heart Failure in Emergency Departement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</source>
  <oversight_info>
    <has_dmc>Yes</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 performance of STIs and clinical scores alone and their combination to predict short term&#xD;
      prognosis of acute decompensated heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute heart failure is a leading cause of hospitalization and death.Prediction of these&#xD;
      adverse events is still challenging.&#xD;
&#xD;
      STI is an old technique based on the recording of two parameters: electrocardiogram and&#xD;
      phonocardiogram, and from them measuring the different systolic intervals:&#xD;
&#xD;
      pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection&#xD;
      time (LVET) and systolic time ratio (RTS) were measured.&#xD;
&#xD;
      The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve&#xD;
      clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get&#xD;
      With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in&#xD;
      patients with acute decompensated heart failure (ADHF) in the ED.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>compare the STIs prognostic performance against clinical scores</measure>
    <time_frame>30 days</time_frame>
    <description>the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>compare the STI prognostic performance between HFpEF and HFrEF patients</measure>
    <time_frame>30 days</time_frame>
    <description>compare the STI prognostic performance between HFpEF and HFrEF patients using the area under curve estimation of the ROC curve of the three systolic time intervals (PEP;EMAT measured in milliseconds,and PEP/EMAT) of the two groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">642</enrollment>
  <condition>Dyspnea</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>AHF/HFpEF</arm_group_label>
    <description>AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AHF/HFrEF</arm_group_label>
    <description>AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>biopac</intervention_name>
    <description>Acoustic cardiography was performed for all participants using the BIOPAC system with &quot;Student Lab&quot; software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.</description>
    <arm_group_label>AHF/HFpEF</arm_group_label>
    <arm_group_label>AHF/HFrEF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>prognostic scores</intervention_name>
    <description>Effect and GWTGHF were calculated for every patient</description>
    <arm_group_label>AHF/HFpEF</arm_group_label>
    <arm_group_label>AHF/HFrEF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients aged more than 18 years admitted to the ED with the diagnosis of acute&#xD;
        decompensated heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non traumatic dyspnea&#xD;
&#xD;
          -  age more than 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECG diagnostic for acute myocardial infarction&#xD;
&#xD;
          -  ischemic chest pain within the prior 24 hours&#xD;
&#xD;
          -  history of a heart transplant&#xD;
&#xD;
          -  pericardial effusion&#xD;
&#xD;
          -  chest wall deformity suspected of causing dyspnea&#xD;
&#xD;
          -  coma&#xD;
&#xD;
          -  shock,Mechanical Ventilation, vasopressor drugs&#xD;
&#xD;
          -  arrhythmia serious and sustained,&#xD;
&#xD;
          -  pace maker&#xD;
&#xD;
          -  severe mitral valve disease,&#xD;
&#xD;
          -  severe pulmonary arterial hypertension&#xD;
&#xD;
          -  renal failure with creatinine &gt;350micromol/l&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nouira Semir, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University hospital of Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia</name>
      <address>
        <city>Monastir</city>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <link>
    <url>http://www.urgencemonastir.com</url>
    <description>official department website</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2018</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>impedance</keyword>
  <keyword>dyspnea</keyword>
  <keyword>AHF</keyword>
  <keyword>BNP</keyword>
  <keyword>EFFECT</keyword>
  <keyword>GWTG-HF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Emergencies</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/NCT03831204
org study id: STI in AHF prognostic
nct id: NCT03831204
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The performance of STIs and clinical scores alone and their combination to predict short term
      prognosis of acute decompensated heart failure.
Acute heart failure is a leading cause of hospitalization and death.Prediction of these
      adverse events is still challenging.

      STI is an old technique based on the recording of two parameters: electrocardiogram and
      phonocardiogram, and from them measuring the different systolic intervals:

      pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection
      time (LVET) and systolic time ratio (RTS) were measured.

      The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve
      clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get
      With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in
      patients with acute decompensated heart failure (ADHF) in the ED.
observational model: Case-Control
time perspective: Prospective
measure: compare the STIs prognostic performance against clinical scores
time frame: 30 days
description: the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores
measure: compare the STI prognostic performance between HFpEF and HFrEF patients
time frame: 30 days
description: compare the STI prognostic performance between HFpEF and HFrEF patients using the area under curve estimation of the ROC curve of the three systolic time intervals (PEP;EMAT measured in milliseconds,and PEP/EMAT) of the two groups
arm group label: AHF/HFpEF
description: AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient
arm group label: AHF/HFrEF
description: AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient
intervention type: Device
intervention name: biopac
description: Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.
arm group label: AHF/HFpEF
arm group label: AHF/HFrEF
intervention type: Diagnostic Test
intervention name: prognostic scores
description: Effect and GWTGHF were calculated for every patient
arm group label: AHF/HFpEF
arm group label: AHF/HFrEF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nouira Semir, Pr
role: Principal Investigator
affiliation: University hospital of Monastir
facility: 
country: Tunisia
url: http://www.urgencemonastir.com
description: official department website
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: Professor
mesh term: Dyspnea
mesh term: Heart Failure
mesh term: Emergencies