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/NCT05991219</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-32/2023</org_study_id>
      <nct_id>NCT05991219</nct_id>
    </id_info>
    <brief_title>Screening and Secondary Prevention Rheumatic Heart Disease Study</brief_title>
    <acronym>S2-RHD</acronym>
    <official_title>Screening and Secondary Prevention Rheumatic Heart Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Cardiovascular Diseases, Pakistan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        After basic clinical screening including history and physical, Point of care ultrasound will&#xD;
        be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis.&#xD;
        For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending&#xD;
        on stage of disease. Antibiotic prescription could be shifted to community health workers&#xD;
        delivering preventive medications via practical clinical algorithms, diagnostic tools,&#xD;
        availability of appropriate antibiotics, and supportive supervision. Patients will have&#xD;
        repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve&#xD;
        disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Screening for RHD should be carried out since it is a major health concern that has been&#xD;
        shown to have a treatable and detectable latent stage that can be diagnosed using a simple&#xD;
        sensitive test (point of care ultrasound) and early treatment (secondary prevention using&#xD;
        antibiotic prophylaxis) can provide a better outcome (slow progression of disease) in a cost&#xD;
        effective way. The investigators aim to study the Incidence and Prevalence of RHD in&#xD;
        community and school settings and aim to intervene depending on the stage the disease is&#xD;
        picked up in.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 26, 2022</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</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rheumatic heart disease</measure>
      <time_frame>At the time of screening echocardiogram</time_frame>
      <description>Number of patients</description>
    </primary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Rheumatic Heart Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Age group 10-30 years. Screening in rural communities in Sindh including very low income&#xD;
          areas outside Karachi. Schools (free government schools in low income areas) and patient&#xD;
          point of contact locations such as National Institute of Cardiovascular Diseases Pakistan&#xD;
          Satellite centers (10) and chest pain units (24) will also be utilized. Family members of&#xD;
          patients with known rheumatic heart disease will also be screened.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Rural communities in Sindh&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refused to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</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>
    <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>
    </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 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Rheumatic Heart Disease</mesh_term>
      <mesh_term>Rheumatic Diseases</mesh_term>
      <mesh_term>Heart 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/NCT05991219
  org study id: IRB-32/2023
  nct id: NCT05991219
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  After basic clinical screening including history and physical, Point of care ultrasound will
        be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis.
        For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending
        on stage of disease. Antibiotic prescription could be shifted to community health workers
        delivering preventive medications via practical clinical algorithms, diagnostic tools,
        availability of appropriate antibiotics, and supportive supervision. Patients will have
        repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve
        disease.
  Screening for RHD should be carried out since it is a major health concern that has been
        shown to have a treatable and detectable latent stage that can be diagnosed using a simple
        sensitive test (point of care ultrasound) and early treatment (secondary prevention using
        antibiotic prophylaxis) can provide a better outcome (slow progression of disease) in a cost
        effective way. The investigators aim to study the Incidence and Prevalence of RHD in
        community and school settings and aim to intervene depending on the stage the disease is
        picked up in.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Rheumatic heart disease
  time frame: At the time of screening echocardiogram
  description: Number of patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  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
  facility: 
  status: Recruiting
  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: Rheumatic Heart Disease
  mesh term: Rheumatic Diseases
  mesh term: Heart Diseases
  sharing ipd: No