<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/NCT02970071</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-036</org_study_id>
    <nct_id>NCT02970071</nct_id>
  </id_info>
  <brief_title>The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease</brief_title>
  <acronym>STIC</acronym>
  <official_title>The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to use of STIC technology to assist the traditional&#xD;
      echocardiography to diagnose the fetal congenital heart disease accurately and then to&#xD;
      provide a basis for prenatal counseling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases&#xD;
      are gravidas with fetal congenital heart disease diagnosed by echocardiography.Only gravidas&#xD;
      who are willing to have complete pregnancy checks and finally delivery or abortion in the&#xD;
      hospital are interviewed are eligible for the study. Study participants will be asked for&#xD;
      their informed consent.We collect their fetal 2D echocardiography and STIC images every 4-6&#xD;
      weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal&#xD;
      echocardiography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal Congenital heart disease</measure>
    <time_frame>Nov 2016 to Dec 2018</time_frame>
    <description>If an enrolled gravida chooses to terminate her pregnancy, autopsy confirmation will be performed ;If the gravida continues her pregnancy, the outcome will be measured by neonatal echocardiography or surgery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">265</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Fetal congenital heart disease cases</arm_group_label>
    <description>Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Gravidas with singleton pregnancy living in SHANGHAI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gravida with singleton pregnancy taking fetal echocardiography.&#xD;
&#xD;
          2. No virus infection or drug use history, no harmful substances in the early pregnancy.&#xD;
&#xD;
          3. Complete pregnancy check in the hospital, and finally delivery or abortion in the&#xD;
             hospital.&#xD;
&#xD;
          4. On the basis of informed consent，willing to cooperate with our group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Elderly pregnant women (&gt;35 years old)&#xD;
&#xD;
          2. Twin or multiple pregnancy&#xD;
&#xD;
          3. Pregnant women suffering from mental illness, can't take care of themselves.&#xD;
&#xD;
          4. Fetus diagnosed with other abnormalities (except congenital heart defects)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinhua Hospital Shanghai Jiao Tong University School of Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chen Sun, MD</last_name>
    <phone>8621-25078485</phone>
    <email>chengsun@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sun Kun, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xinhua Hospital,Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Yangpu</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sun Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F33-5. doi: 10.1136/adc.2007.119032. Epub 2007 Jun 7.</citation>
    <PMID>17556383</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim N, Friedberg MK, Silverman NH. Diagnosis and prognosis of fetuses with double outlet right ventricle. Prenat Diagn. 2006 Aug;26(8):740-5. doi: 10.1002/pd.1500.</citation>
    <PMID>16807954</PMID>
  </results_reference>
  <results_reference>
    <citation>DeVore GR, Falkensammer P, Sklansky MS, Platt LD. Spatio-temporal image correlation (STIC): new technology for evaluation of the fetal heart. Ultrasound Obstet Gynecol. 2003 Oct;22(4):380-7. doi: 10.1002/uog.217.</citation>
    <PMID>14528474</PMID>
  </results_reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>October 24, 2018</last_update_submitted>
  <last_update_submitted_qc>October 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spatio-Temporal Image Correlation</keyword>
  <keyword>Complicated congenital heart disease</keyword>
  <keyword>Echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02970071
org study id: XH-16-036
nct id: NCT02970071
lead sponsor: 
has dmc: Yes
The objective of this study is to use of STIC technology to assist the traditional
      echocardiography to diagnose the fetal congenital heart disease accurately and then to
      provide a basis for prenatal counseling.
This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases
      are gravidas with fetal congenital heart disease diagnosed by echocardiography.Only gravidas
      who are willing to have complete pregnancy checks and finally delivery or abortion in the
      hospital are interviewed are eligible for the study. Study participants will be asked for
      their informed consent.We collect their fetal 2D echocardiography and STIC images every 4-6
      weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal
      echocardiography.
observational model: Case-Only
time perspective: Prospective
measure: Fetal Congenital heart disease
time frame: Nov 2016 to Dec 2018
description: If an enrolled gravida chooses to terminate her pregnancy, autopsy confirmation will be performed ;If the gravida continues her pregnancy, the outcome will be measured by neonatal echocardiography or surgery.
arm group label: Fetal congenital heart disease cases
description: Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xinhua Hospital Shanghai Jiao Tong University School of Medicine
role: Principal Investigator
affiliation: Investigator
last name: Chen Sun, MD
phone: 8621-25078485
email: chengsun@hotmail.com
last name: Sun Kun, MD
facility: 
status: Recruiting
investigator: 
country: China
citation: Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F33-5. doi: 10.1136/adc.2007.119032. Epub 2007 Jun 7.
PMID: 17556383
citation: Kim N, Friedberg MK, Silverman NH. Diagnosis and prognosis of fetuses with double outlet right ventricle. Prenat Diagn. 2006 Aug;26(8):740-5. doi: 10.1002/pd.1500.
PMID: 16807954
citation: DeVore GR, Falkensammer P, Sklansky MS, Platt LD. Spatio-temporal image correlation (STIC): new technology for evaluation of the fetal heart. Ultrasound Obstet Gynecol. 2003 Oct;22(4):380-7. doi: 10.1002/uog.217.
PMID: 14528474
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: Undecided