<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/NCT04498299</url>
  </required_header>
  <id_info>
    <org_study_id>Cardiology-004</org_study_id>
    <nct_id>NCT04498299</nct_id>
  </id_info>
  <brief_title>Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness</brief_title>
  <acronym>ECHO-vid</acronym>
  <official_title>Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miguel Ayala León</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Beneficencia Espanola de Puebla</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>
      With the appearance of the new SARS-COV2 virus, additional challenges are being imposed on&#xD;
      the medical community after the resolution of acute COVID-19 illness, resulting in specific&#xD;
      pathophysiologic mechanisms that while acutely damage the lung parenchyma might chronically&#xD;
      impact the cardiopulmonary system.&#xD;
&#xD;
      This study aims to investigate changes after mild COVID-19 illness in echocardiographic&#xD;
      indices at rest and stress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>• LA volume index</measure>
    <time_frame>3 minutes</time_frame>
    <description>Left atrium volume index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• LV telediastolic diameter</measure>
    <time_frame>3 minutes</time_frame>
    <description>Left ventricle telediastolic diameter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• LV telesystolic diameter</measure>
    <time_frame>3 minutes</time_frame>
    <description>Left ventricle telesystolic diameter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• LV posterior wall</measure>
    <time_frame>3 minutes</time_frame>
    <description>Left ventricle posterior wall</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• RA area</measure>
    <time_frame>3 minutes</time_frame>
    <description>Right atrium area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• RV basal dimensión</measure>
    <time_frame>3 minutes</time_frame>
    <description>Right ventricle basal dimensión</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• RV mid cavity dimension;</measure>
    <time_frame>3 minutes</time_frame>
    <description>Right ventricle cavity dimensión</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• RV longitudinal dimension</measure>
    <time_frame>3 minutes</time_frame>
    <description>Right ventricle longitudinal dimension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Distal, RV outflow tract dimension at the distal or pulmonic valve level</measure>
    <time_frame>3 minutes</time_frame>
    <description>Distal, right ventricle outflow tract dimension at the distal or pulmonic valve level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Proximal RV outflow tract dimension at the proximal subvalvular level</measure>
    <time_frame>3 minutes</time_frame>
    <description>Proximal right ventricle outflow tract dimension at the proximal subvalvular level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• TAPSE</measure>
    <time_frame>3 minutes</time_frame>
    <description>• Tricuspid annular plane systolic excursion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• RV free Wall strain</measure>
    <time_frame>3 minutes</time_frame>
    <description>Right ventricle free Wall strain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Inferior cava vein PW Doppler</measure>
    <time_frame>3 minutes</time_frame>
    <description>Inferior cava vein PW Doppler</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E wave mitral</measure>
    <time_frame>3 minutes</time_frame>
    <description>E wave mitral</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• A wave mitral</measure>
    <time_frame>3 minutes</time_frame>
    <description>A wave mitral</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E wave /A wave mitral</measure>
    <time_frame>3 minutes</time_frame>
    <description>E wave /A wave mitral</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E-wave at mitral annulus</measure>
    <time_frame>3 minutes</time_frame>
    <description>E-wave at mitral annulus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E-wave at mitral annulus / A-wave at the mitral annulus</measure>
    <time_frame>3 minutes</time_frame>
    <description>E-wave at mitral annulus / A-wave at the mitral annulus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E wave/ E-wave at the mitral annulus</measure>
    <time_frame>3 minutes</time_frame>
    <description>E wave/ E-wave at the mitral annulus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E tricuspid (E)</measure>
    <time_frame>3 minutes</time_frame>
    <description>E tricuspid (E)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• A tricuspid (A)</measure>
    <time_frame>3 minutes</time_frame>
    <description>A triuspid (A)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E/A</measure>
    <time_frame>3 minutes</time_frame>
    <description>E/A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Systolic pulmonary artery pressure</measure>
    <time_frame>3 minutes</time_frame>
    <description>Systolic pulmonary artery pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• E-wave at the tricuspid annulus</measure>
    <time_frame>3 minutes</time_frame>
    <description>E-wave at the tricuspid annulus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Mean pulmonary artery pressure</measure>
    <time_frame>3 minutes</time_frame>
    <description>Mean pulmonary artery pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Stroke volume</measure>
    <time_frame>3 minutes</time_frame>
    <description>Stroke volume</description>
  </primary_outcome>
  <primary_outcome>
    <measure>• Cardiac output</measure>
    <time_frame>3 minutes</time_frame>
    <description>Cardiac output</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Echocardiography, Stress</condition>
  <condition>COVID-19</condition>
  <condition>Hypertension, Pulmonary</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>echocardiogram 2D</intervention_name>
    <description>The patient is accelerating against a workload that gradually increases at a constant rate during the exercise, images will be obtained by echocardiography. The patient begins with 25 Watts with increments of 25 Watts every 3 minutes, continuing the exercise until significant electrocardiographic changes occur or the patient starts with symptoms.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients after the resolution of acute COVID-19 illness&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having suffered mild COVID-19 illness&#xD;
&#xD;
          -  PCR test negative after COVID-19 illness&#xD;
&#xD;
          -  Men or women&#xD;
&#xD;
          -  Age ≥18 years and &lt; 45.&#xD;
&#xD;
          -  No history of other cardiovascular or lung disease.&#xD;
&#xD;
          -  No cardiovascular risk factors, that is, arterial systemic hypertension, smoking,&#xD;
             diabetes, dyslipidemia&#xD;
&#xD;
          -  No ongoing or previous cardio or vasoactive treatment&#xD;
&#xD;
          -  Able to use the semi-supine exercise bicycle&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor acoustic window.&#xD;
&#xD;
          -  Tricuspid regurgitation more than mild&#xD;
&#xD;
          -  Professional sports activity&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Obesity (body mass index [BMI], ≥30 kg/m2).&#xD;
&#xD;
          -  Inability to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>miguel ayala-leon</last_name>
    <phone>5529625396</phone>
    <email>terapia_intensiva_miguel@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Beneficencia Española de Puebla</name>
      <address>
        <city>Puebla</city>
        <zip>72090</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miguel Ayala León, Cardiolology</last_name>
      <phone>5529625396</phone>
      <email>librocardicoritica.ma@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Miguel Ayala-Leon</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rosa Tzompantzi-Flores</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Consuelo Orihuela Sandoval</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jaime Hernandez-Montfort</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Victoria Delgado</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Beneficencia Espanola de Puebla</investigator_affiliation>
    <investigator_full_name>Miguel Ayala León</investigator_full_name>
    <investigator_title>cardiovascular critical care unit director</investigator_title>
  </responsible_party>
  <keyword>Echocardiography, Stress</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Pulmonary Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04498299
org study id: Cardiology-004
nct id: NCT04498299
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
With the appearance of the new SARS-COV2 virus, additional challenges are being imposed on
      the medical community after the resolution of acute COVID-19 illness, resulting in specific
      pathophysiologic mechanisms that while acutely damage the lung parenchyma might chronically
      impact the cardiopulmonary system.

      This study aims to investigate changes after mild COVID-19 illness in echocardiographic
      indices at rest and stress.
observational model: Cohort
time perspective: Prospective
measure: • LA volume index
time frame: 3 minutes
description: Left atrium volume index
measure: • LV telediastolic diameter
time frame: 3 minutes
description: Left ventricle telediastolic diameter
measure: • LV telesystolic diameter
time frame: 3 minutes
description: Left ventricle telesystolic diameter
measure: • LV posterior wall
time frame: 3 minutes
description: Left ventricle posterior wall
measure: • RA area
time frame: 3 minutes
description: Right atrium area
measure: • RV basal dimensión
time frame: 3 minutes
description: Right ventricle basal dimensión
measure: • RV mid cavity dimension;
time frame: 3 minutes
description: Right ventricle cavity dimensión
measure: • RV longitudinal dimension
time frame: 3 minutes
description: Right ventricle longitudinal dimension
measure: • Distal, RV outflow tract dimension at the distal or pulmonic valve level
time frame: 3 minutes
description: Distal, right ventricle outflow tract dimension at the distal or pulmonic valve level
measure: • Proximal RV outflow tract dimension at the proximal subvalvular level
time frame: 3 minutes
description: Proximal right ventricle outflow tract dimension at the proximal subvalvular level
measure: • TAPSE
time frame: 3 minutes
description: • Tricuspid annular plane systolic excursion
measure: • RV free Wall strain
time frame: 3 minutes
description: Right ventricle free Wall strain
measure: • Inferior cava vein PW Doppler
time frame: 3 minutes
description: Inferior cava vein PW Doppler
measure: • E wave mitral
time frame: 3 minutes
description: E wave mitral
measure: • A wave mitral
time frame: 3 minutes
description: A wave mitral
measure: • E wave /A wave mitral
time frame: 3 minutes
description: E wave /A wave mitral
measure: • E-wave at mitral annulus
time frame: 3 minutes
description: E-wave at mitral annulus
measure: • E-wave at mitral annulus / A-wave at the mitral annulus
time frame: 3 minutes
description: E-wave at mitral annulus / A-wave at the mitral annulus
measure: • E wave/ E-wave at the mitral annulus
time frame: 3 minutes
description: E wave/ E-wave at the mitral annulus
measure: • E tricuspid (E)
time frame: 3 minutes
description: E tricuspid (E)
measure: • A tricuspid (A)
time frame: 3 minutes
description: A triuspid (A)
measure: • E/A
time frame: 3 minutes
description: E/A
measure: • Systolic pulmonary artery pressure
time frame: 3 minutes
description: Systolic pulmonary artery pressure
measure: • E-wave at the tricuspid annulus
time frame: 3 minutes
description: E-wave at the tricuspid annulus
measure: • Mean pulmonary artery pressure
time frame: 3 minutes
description: Mean pulmonary artery pressure
measure: • Stroke volume
time frame: 3 minutes
description: Stroke volume
measure: • Cardiac output
time frame: 3 minutes
description: Cardiac output
intervention type: Diagnostic Test
intervention name: echocardiogram 2D
description: The patient is accelerating against a workload that gradually increases at a constant rate during the exercise, images will be obtained by echocardiography. The patient begins with 25 Watts with increments of 25 Watts every 3 minutes, continuing the exercise until significant electrocardiographic changes occur or the patient starts with symptoms.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: miguel ayala-leon
phone: 5529625396
email: terapia_intensiva_miguel@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Mexico
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Beneficencia Espanola de Puebla
investigator full name: Miguel Ayala León
investigator title: cardiovascular critical care unit director
mesh term: COVID-19
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
sharing ipd: No