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/NCT05987891</url>
    </required_header>
    <id_info>
      <org_study_id>Pró-Coração</org_study_id>
      <nct_id>NCT05987891</nct_id>
    </id_info>
    <brief_title>Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test</brief_title>
    <acronym>ERGO-RISC</acronym>
    <official_title>The Influence of Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test in Asymptomatically Subjects: a Clinical Perspective (ERGO-RISC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Sao Paulo</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 goal of this observational cross-sectional study is to analyze the effect of&#xD;
        cardiovascular risk factors in healthy and asymptomatic populations. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  Does the combination of the presence of different risk factors increase the risk for&#xD;
             abnormalities appearing on electrocardiograms, such as ischemia, arrhythmia, and&#xD;
             hemodynamics effects during and at the peak of effort of treadmill exercise test?&#xD;
  &#xD;
          -  What are the main differences observed in the recovery period? Participants will answer&#xD;
             an anamnesis of risk factors such as sex, race, age, familiar history of coronary artery&#xD;
             disease, overweight or obesity, smoking, stress, and physical activity practice and&#xD;
             perform treadmill exercise test on Ellestad protocol. If there a comparison groups:&#xD;
             Researchers will compare individuals with most risk factors with those without, to see&#xD;
             the cardiovascular responses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main outcomes broad the effect of simples and easy doccumented cardiovascular risk&#xD;
        factors such as sex, race, age, familiar history of coronary artery disease, overweight or&#xD;
        obesity, smoking, stress, and physical inactivity on electrocardiogram and hemodinamics&#xD;
        abnormalities during and after exercise treadmill exercise test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>ECG abnormalities and risk factors</measure>
      <time_frame>1 year</time_frame>
      <description>Electrocardiogram suggestive of myocardial ischemia</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <condition>Cardiovascular Abnormalities</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
      <description>Volunteers will perform treadmill exercise tests. It will be monitored electrocardiogram, heart rate, and blood pressure in the rest state, under exercise, and in the recovery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Treadmill exercise stress test</intervention_name>
      <description>Ellestad protocol will be applied in all subjects up to fatigue and recovery will be monitored.</description>
      <arm_group_label>Healthy controls</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy and assymptomatically subjects who are visiting cardiologyst for routine.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects that can complete the treadmill exercise test with the Ellestad protocol with&#xD;
               6 minutes of recovery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of remedies for blood pressure, glycemia, cholesterol, and serum lipids;&#xD;
  &#xD;
            -  Symptomatically subjects;&#xD;
  &#xD;
            -  Electrocardiogram that are not able to be interpreted;&#xD;
  &#xD;
            -  Blood pressure in rest state ≥180 mmHg and ≥110 mmHg, for systolic and diastolic,&#xD;
               respectively.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pedro GS Braga, Ph.D.</last_name>
      <phone>5511 94104-4044</phone>
      <email>pedro.senger@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Pró-Coração</name>
        <address>
          <city>São Paulo</city>
          <state>SP</state>
          <zip>05021-010</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paulo Dourado, MD, PhD</last_name>
        <email>pmdourado@terra.com.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 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>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
      <investigator_full_name>Pedro Gabriel Senger Braga</investigator_full_name>
      <investigator_title>Ph.D.</investigator_title>
    </responsible_party>
    <keyword>treadmill exercise test</keyword>
    <keyword>asymptomatic subjects</keyword>
    <keyword>Cardiovascular risk factor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Cardiovascular Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987891
  org study id: Pró-Coração
  nct id: NCT05987891
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational cross-sectional study is to analyze the effect of
        cardiovascular risk factors in healthy and asymptomatic populations. The main questions it
        aims to answer are:
  
          -  Does the combination of the presence of different risk factors increase the risk for
             abnormalities appearing on electrocardiograms, such as ischemia, arrhythmia, and
             hemodynamics effects during and at the peak of effort of treadmill exercise test?
  
          -  What are the main differences observed in the recovery period? Participants will answer
             an anamnesis of risk factors such as sex, race, age, familiar history of coronary artery
             disease, overweight or obesity, smoking, stress, and physical activity practice and
             perform treadmill exercise test on Ellestad protocol. If there a comparison groups:
             Researchers will compare individuals with most risk factors with those without, to see
             the cardiovascular responses.
  The main outcomes broad the effect of simples and easy doccumented cardiovascular risk
        factors such as sex, race, age, familiar history of coronary artery disease, overweight or
        obesity, smoking, stress, and physical inactivity on electrocardiogram and hemodinamics
        abnormalities during and after exercise treadmill exercise test.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: ECG abnormalities and risk factors
  time frame: 1 year
  description: Electrocardiogram suggestive of myocardial ischemia
  arm group label: Healthy controls
  description: Volunteers will perform treadmill exercise tests. It will be monitored electrocardiogram, heart rate, and blood pressure in the rest state, under exercise, and in the recovery.
  intervention type: Diagnostic Test
  intervention name: Treadmill exercise stress test
  description: Ellestad protocol will be applied in all subjects up to fatigue and recovery will be monitored.
  arm group label: Healthy controls
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pedro GS Braga, Ph.D.
  phone: 5511 94104-4044
  email: pedro.senger@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: University of Sao Paulo
  investigator full name: Pedro Gabriel Senger Braga
  investigator title: Ph.D.
  mesh term: Cardiovascular Diseases
  mesh term: Cardiovascular Abnormalities
  sharing ipd: No