<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/NCT04407728</url>
  </required_header>
  <id_info>
    <org_study_id>38RC20.009</org_study_id>
    <nct_id>NCT04407728</nct_id>
  </id_info>
  <brief_title>Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease</brief_title>
  <acronym>PRECAFOET</acronym>
  <official_title>Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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 main objective of the work is to evaluate, in the French health care system, the&#xD;
      performance of early ultrasound screening for severe heart disease between 11 and 14SA in&#xD;
      high-risk populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Numerous studies have shown a link between increased nuchal translucency and heart disease.&#xD;
      Although high-risk fetal populations are identified between 11 and 13 SA on clinical and&#xD;
      biological criteria and by screening ultrasound (Echo T1), cardiac morphology analysis is&#xD;
      routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22&#xD;
      SA (EchoMorpho-T2) inducing a difficult wait for the couple.&#xD;
&#xD;
      The development of increasingly efficient ultrasound probes has made it possible to explore&#xD;
      the foetal heart at an earlier stage. International learned societies recommend an early&#xD;
      morphological examination with heart-centered slices before 14 weeks in high-risk situations.&#xD;
      This practice is not systematic in France and no study has evaluated its feasibility and&#xD;
      impact in a French care network.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 15, 2020</start_date>
  <completion_date type="Anticipated">November 2, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>early ultrasound screening</measure>
    <time_frame>1 day</time_frame>
    <description>Calculation of the sensitivity and specificity of screening for severe heart disease using EchoMorpho-T1. Specificity will be privileged in order to avoid the anxiety-producing nature of false positives.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>precocious EchoMorpho-T1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women whose fetus is at high risk of congenital heart disease after the 1st trimester screening echo (EchoT1), will benefit from an early morphological ultrasound centered on the heart (EchoMorpho-T1) by a sonographer referent between 11 and 14 weeks +/- of an early fetal heart ultrasound (EchoCoeur-T1) between 11 and 15 weeks by a cardio-pediatrician in the event of an abnormality with the EchoMorpho-T1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>early ultrasound screening</intervention_name>
    <description>Women whose fetus is at high risk of congenital heart disease at the end of the 1st trimester screening ultrasound (EchoT1), will benefit from an early heart-centered morphological ultrasound (EchoMorpho-T1) by a referring sonographer between 11 and 14 SA +/- an early fetal cardiac ultrasound (EchoCoeur-T1) between 11 and 15 SA by a cardio-paediatrician in case of EchoMorpho-T1 abnormality.&#xD;
The results of the early morphological and cardiac ultrasounds will be compared with those of the 2nd trimester ultrasound at 18-22SA (EchoMorpho-T2) and +/- of the fetal cardiac ultrasound between 18SA and 24SA (Gold standard) or, failing this, with the anatomopathological examination when it is available if a medical termination of pregnancy took place before the EchoMorpho-T2.</description>
    <arm_group_label>precocious EchoMorpho-T1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pregnant women whose fetus is at high risk for congenital heart disease:&#xD;
&#xD;
          -  Nuchal translucency measurement on T1 echo ≥3.5mm&#xD;
&#xD;
          -  Cardiac or extra-cardiac morphological abnormality suspected on the T1 screening echo&#xD;
&#xD;
          -  First degree family history for the fetus (patient, spouse, 1st children of the&#xD;
             couple) of significant congenital cardiopathy (excluding AIC, muscular VIC or&#xD;
             persistent CA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple Pregnancies&#xD;
&#xD;
          -  non-emancipated minors, persons unable to express their consent.&#xD;
&#xD;
          -  Lack of affiliation to a social security scheme.&#xD;
&#xD;
          -  Subject in a period of exclusion from another study,&#xD;
&#xD;
          -  Subject under administrative or judicial supervision&#xD;
&#xD;
          -  Subject cannot be contacted in case of emergency&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthias LACHAUD, PH</last_name>
    <phone>0476769495</phone>
    <phone_ext>+ 33</phone_ext>
    <email>MLachaud@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lora PEJOT, CRA</last_name>
    <phone>0476766561</phone>
    <phone_ext>+33</phone_ext>
    <email>LPejot@chu-grenoble.fr</email>
  </overall_contact_backup>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</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/NCT04407728
org study id: 38RC20.009
nct id: NCT04407728
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objective of the work is to evaluate, in the French health care system, the
      performance of early ultrasound screening for severe heart disease between 11 and 14SA in
      high-risk populations.
Numerous studies have shown a link between increased nuchal translucency and heart disease.
      Although high-risk fetal populations are identified between 11 and 13 SA on clinical and
      biological criteria and by screening ultrasound (Echo T1), cardiac morphology analysis is
      routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22
      SA (EchoMorpho-T2) inducing a difficult wait for the couple.

      The development of increasingly efficient ultrasound probes has made it possible to explore
      the foetal heart at an earlier stage. International learned societies recommend an early
      morphological examination with heart-centered slices before 14 weeks in high-risk situations.
      This practice is not systematic in France and no study has evaluated its feasibility and
      impact in a French care network.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: early ultrasound screening
time frame: 1 day
description: Calculation of the sensitivity and specificity of screening for severe heart disease using EchoMorpho-T1. Specificity will be privileged in order to avoid the anxiety-producing nature of false positives.
arm group label: precocious EchoMorpho-T1
arm group type: Experimental
description: Women whose fetus is at high risk of congenital heart disease after the 1st trimester screening echo (EchoT1), will benefit from an early morphological ultrasound centered on the heart (EchoMorpho-T1) by a sonographer referent between 11 and 14 weeks +/- of an early fetal heart ultrasound (EchoCoeur-T1) between 11 and 15 weeks by a cardio-pediatrician in the event of an abnormality with the EchoMorpho-T1.
intervention type: Other
intervention name: early ultrasound screening
description: Women whose fetus is at high risk of congenital heart disease at the end of the 1st trimester screening ultrasound (EchoT1), will benefit from an early heart-centered morphological ultrasound (EchoMorpho-T1) by a referring sonographer between 11 and 14 SA +/- an early fetal cardiac ultrasound (EchoCoeur-T1) between 11 and 15 SA by a cardio-paediatrician in case of EchoMorpho-T1 abnormality.
The results of the early morphological and cardiac ultrasounds will be compared with those of the 2nd trimester ultrasound at 18-22SA (EchoMorpho-T2) and +/- of the fetal cardiac ultrasound between 18SA and 24SA (Gold standard) or, failing this, with the anatomopathological examination when it is available if a medical termination of pregnancy took place before the EchoMorpho-T2.
arm group label: precocious EchoMorpho-T1
criteria: 
gender: Female
minimum age: 18 Months
maximum age: N/A
healthy volunteers: No
last name: Matthias LACHAUD, PH
phone: 0476769495
phone ext: + 33
email: MLachaud@chu-grenoble.fr
last name: Lora PEJOT, CRA
phone: 0476766561
phone ext: +33
email: LPejot@chu-grenoble.fr
responsible party type: Sponsor
mesh term: Heart Diseases
sharing ipd: Undecided