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/NCT06004544</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-33/2023</org_study_id>
      <nct_id>NCT06004544</nct_id>
    </id_info>
    <brief_title>Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women</brief_title>
    <acronym>PRESAP</acronym>
    <official_title>Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Cardiovascular Diseases, Pakistan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jinnah Postgraduate Medical Centre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Institute of Cardiovascular Diseases, Pakistan</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>
        Consecutive obstetric patients attending routine antenatal visits were enrolled in this&#xD;
        ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed.&#xD;
        Ejection fraction (EF) was quantified using biplane Simpson's method.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Consecutive obstetric patients attending routine antenatal visits were enrolled in this&#xD;
        ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed,&#xD;
        including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and&#xD;
        pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left&#xD;
        ventricular (LV) function was quantified using biplane Simpson's method and visually assessed&#xD;
        by two independent readers. Patients with significant valve disease or congenital heart&#xD;
        disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular&#xD;
        diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and&#xD;
        long-term follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 6, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Number of participants found to have abnormal left ventricular function</measure>
      <time_frame>At the time of screening echocardiogram</time_frame>
      <description>Prevalence of Left ventricular dysfunction (Ejection Fraction&lt;55%)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants found to have abnormal heart valve function</measure>
      <time_frame>At the time of screening echocardiogram</time_frame>
      <description>Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants found to have adverse Maternal outcomes</measure>
      <time_frame>At the time of delivery</time_frame>
      <description>Maternal Mortality, Cardiogenic shock</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants found to have adverse Fetal outcomes</measure>
      <time_frame>At the time of delivery</time_frame>
      <description>Infant Mortality, Infant birth weight (kg)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Cardiovascular Diseases in Pregnancy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive obstetric patients attending routine antenatal visits&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Obstetric patients attending routine antenatal visits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients refused to give consent for echocardiography or participation in the study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sabha Bhatti, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Cardiovascular Diseases</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sabha Bhatti, MD</last_name>
      <phone>+92 335 5554346</phone>
      <email>drsabhabhatti@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shakeela Naz, FCPS</last_name>
      <phone>+92 331 3596502</phone>
      <email>dr.shakeela7@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Institute of Cardiovascular Diseases (NICVD)</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>75510</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Sabha Bhatti, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sumyia Gurmani, FCPS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Shakeela Naz, FCPS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Institute of Cardiovascular Diseases, Pakistan</investigator_affiliation>
      <investigator_full_name>Sabha Bhatti</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</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/NCT06004544
  org study id: IRB-33/2023
  nct id: NCT06004544
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Consecutive obstetric patients attending routine antenatal visits were enrolled in this
        ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed.
        Ejection fraction (EF) was quantified using biplane Simpson's method.
  Consecutive obstetric patients attending routine antenatal visits were enrolled in this
        ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed,
        including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and
        pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left
        ventricular (LV) function was quantified using biplane Simpson's method and visually assessed
        by two independent readers. Patients with significant valve disease or congenital heart
        disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular
        diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and
        long-term follow-up.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants found to have abnormal left ventricular function
  time frame: At the time of screening echocardiogram
  description: Prevalence of Left ventricular dysfunction (Ejection Fraction<55%)
  measure: Number of participants found to have abnormal heart valve function
  time frame: At the time of screening echocardiogram
  description: Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)
  measure: Number of participants found to have adverse Maternal outcomes
  time frame: At the time of delivery
  description: Maternal Mortality, Cardiogenic shock
  measure: Number of participants found to have adverse Fetal outcomes
  time frame: At the time of delivery
  description: Infant Mortality, Infant birth weight (kg)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Sabha Bhatti, MD
  role: Principal Investigator
  affiliation: National Institute of Cardiovascular Diseases
  last name: Sabha Bhatti, MD
  phone: +92 335 5554346
  email: drsabhabhatti@gmail.com
  last name: Shakeela Naz, FCPS
  phone: +92 331 3596502
  email: dr.shakeela7@gmail.com
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  investigator: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: National Institute of Cardiovascular Diseases, Pakistan
  investigator full name: Sabha Bhatti
  investigator title: Professor
  mesh term: Cardiovascular Diseases
  sharing ipd: No