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/NCT05979870</url>
    </required_header>
    <id_info>
      <org_study_id>277238</org_study_id>
      <nct_id>NCT05979870</nct_id>
    </id_info>
    <brief_title>Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease</brief_title>
    <acronym>AI-CMR</acronym>
    <official_title>Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease -Improving the Assessment, Monitoring and Prediction in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sahlgrenska University Hospital, Sweden</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sahlgrenska University Hospital, Sweden</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>
        The goal of this study is to investigate children with aortic and pulmonary valve disease&#xD;
        treated or untreated longitudinally. Established CMR measures with additional newly&#xD;
        developped, promising, highly refined and clinically applicable quantitative imaging&#xD;
        biomarkers, will be utilized as compared to the conventional CMR estimates.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  [question 1]To evaluate risk stratification for surgery and intervention of the aortic-&#xD;
             and pulmonary valve&#xD;
  &#xD;
          -  [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes&#xD;
             before and after interventional or surgical treatment of the aortic- and pulmonary valve&#xD;
             at short and long term.&#xD;
  &#xD;
        Participants will undergo cardiac MRI before and after interventional or surgical treatment&#xD;
        of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control&#xD;
        group established at the department in another study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        An increasing number of children with complex congenital heart disease (CHD) are today&#xD;
        treated and survive into adulthood. They are in need of a lifelong surveillance for&#xD;
        cardiovascular complications and an individualised treatment.&#xD;
  &#xD;
        In paediatric aortic and pulmonary valve disease, the long-term complications are related to&#xD;
        valvular dysfunction with myocardial fibrosis and ventricular dysfunction as a result of&#xD;
        longstanding volume or pressure overload. Many patients will need surgery or interventional&#xD;
        treatment already in childhood, where the optimal timing of the intervention is crucial,&#xD;
        since early treatment may prevent irreversible injury to the heart.&#xD;
  &#xD;
        Moreover, to enable detection of recurrent or new problems early, a long-term diagnostic&#xD;
        follow-up is needed where cardiovascular magnetic resonance (CMR) has become important for a&#xD;
        serial reproducible assessment of morphology, function and recently advanced methods for flow&#xD;
        and tissue characterisation. Still the the clinical decision of the perfect time-point and&#xD;
        type of treatment for a child, may be difficult in many cases, and better measures are&#xD;
        needed.&#xD;
  &#xD;
        Aim:&#xD;
  &#xD;
        This project will investigate children with aortic and pulmonary valve disease treated or&#xD;
        untreated longitudinally using established CMR measures with additional newly developed,&#xD;
        promising, highly refined and clinically applicable quantitative imaging biomarkers, as&#xD;
        compared to the conventional CMR estimates. Investigators aim to evaluate risk stratification&#xD;
        and investigate the haemodynamic and morphological changes as well as physical capacity&#xD;
        before and after interventional or surgical treatment at short and long term.&#xD;
  &#xD;
        CMR will be analysed for established imaging biomarkers as well as the potential value of new&#xD;
        data-driven computer tools searching for new information in the CMR images i.e. shape/texture&#xD;
        analysis of tissue change, regional haemodynamics, blood flow in relation to metallic&#xD;
        implants and evaluation of myocardial deformation over time.&#xD;
  &#xD;
        CMR measures will be compared to data from echocardiography, catheterization and serological&#xD;
        markers.&#xD;
  &#xD;
        Clinical importance:&#xD;
  &#xD;
        If the new refined CMR biomarkers can reveal improved disease characterisation, they may&#xD;
        reveal feasible in aiding the clinical decision making to optimise timing of intervention and&#xD;
        predicting long term complications. This could contribute to individualise the treatment and&#xD;
        improve health in children with CHD. The study may lead to improved patient care and use of&#xD;
        socio-economical resources.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">October 1, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CMR measures</measure>
      <time_frame>Before and after 6 months, 1 year and up to 3 years after intervention or surgery</time_frame>
      <description>Measurement by CMR of changes in ventricular function, remodelling, tissue characterisation and advanced four dimensional flow (4D-flow) measurements after surgery or intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical capacity</measure>
      <time_frame>Before and after 6 months, 1 year and up to 3 years after intervention or surgery</time_frame>
      <description>Measurement of physical capacity after surgery or intervention, by cardiopulmonary exercise testing (CPET)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CMR derived flow measurements near metallic implants, stents</measure>
      <time_frame>after 6 months, 1 year and up to 3 years after intervention</time_frame>
      <description>Refined measurements of CMR derived 4D-flow measurements near metallic implants, stents</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Aortic Valve Disease</condition>
    <condition>Pulmonary Valve Disease</condition>
    <condition>Child, Only</condition>
    <condition>Magnetic Resonance Imaging</condition>
    <condition>Risk Stratification</condition>
    <arm_group>
      <arm_group_label>Aortic valve disease-operation</arm_group_label>
      <description>Surgery of the aortic valve:&#xD;
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Aortic valve disease-intervention</arm_group_label>
      <description>Interventional treatment of the aortic valve:&#xD;
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulmonary valve disease-operation</arm_group_label>
      <description>Surgery of the pulmonary valve:&#xD;
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulmonary valve disease-intervention</arm_group_label>
      <description>Interventional treatment of the pulmonary valve:&#xD;
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Valvuloplasty,</intervention_name>
      <description>Choice of type of intervention decided on a multidisciplinary conference</description>
      <arm_group_label>Aortic valve disease-intervention</arm_group_label>
      <arm_group_label>Aortic valve disease-operation</arm_group_label>
      <arm_group_label>Pulmonary valve disease-intervention</arm_group_label>
      <arm_group_label>Pulmonary valve disease-operation</arm_group_label>
      <other_name>surgical valvular repair</other_name>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Whole blood, serum&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Childen aged 0-18 years old with aortic or pulmonary valve disease in need of treatment&#xD;
          admitted to the Paediatric Heart Centre, Queen Silvia Childrens' Hospital, Gothenburg&#xD;
          Sweden.&#xD;
  &#xD;
          Patients will be invited to participate in the study after a multidisciplinary conference&#xD;
          on decision of treatment&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aortic valve disease&#xD;
  &#xD;
            -  or pulmonary valve disease&#xD;
  &#xD;
            -  clinical indication for valvular surgery&#xD;
  &#xD;
            -  or clinical indication for valvular intervention&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  contraindications for MRI&#xD;
  &#xD;
            -  need of sedation or general anesthesia, unless there is a clinical indication for a&#xD;
               CMR&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Week</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Charlotte de Lange, MD, Assoc. Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sahlgrenska University hospital, Queen Silvia Childrens' Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Queen Silvia Children'sHospital, Sahlgrenska University Hospital</name>
        <address>
          <city>Gothenburg</city>
          <zip>41560</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
      <investigator_full_name>Charlotte de Lange</investigator_full_name>
      <investigator_title>MD PhD, senior consultant</investigator_title>
    </responsible_party>
    <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>
      <mesh_term>Aortic Valve Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05979870
  org study id: 277238
  nct id: NCT05979870
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to investigate children with aortic and pulmonary valve disease
        treated or untreated longitudinally. Established CMR measures with additional newly
        developped, promising, highly refined and clinically applicable quantitative imaging
        biomarkers, will be utilized as compared to the conventional CMR estimates.
  
        The main question[s] it aims to answer are:
  
          -  [question 1]To evaluate risk stratification for surgery and intervention of the aortic-
             and pulmonary valve
  
          -  [question 2]Investigate the cardiac and vascular hemodynamic and morphological changes
             before and after interventional or surgical treatment of the aortic- and pulmonary valve
             at short and long term.
  
        Participants will undergo cardiac MRI before and after interventional or surgical treatment
        of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control
        group established at the department in another study.
  Background:
  
        An increasing number of children with complex congenital heart disease (CHD) are today
        treated and survive into adulthood. They are in need of a lifelong surveillance for
        cardiovascular complications and an individualised treatment.
  
        In paediatric aortic and pulmonary valve disease, the long-term complications are related to
        valvular dysfunction with myocardial fibrosis and ventricular dysfunction as a result of
        longstanding volume or pressure overload. Many patients will need surgery or interventional
        treatment already in childhood, where the optimal timing of the intervention is crucial,
        since early treatment may prevent irreversible injury to the heart.
  
        Moreover, to enable detection of recurrent or new problems early, a long-term diagnostic
        follow-up is needed where cardiovascular magnetic resonance (CMR) has become important for a
        serial reproducible assessment of morphology, function and recently advanced methods for flow
        and tissue characterisation. Still the the clinical decision of the perfect time-point and
        type of treatment for a child, may be difficult in many cases, and better measures are
        needed.
  
        Aim:
  
        This project will investigate children with aortic and pulmonary valve disease treated or
        untreated longitudinally using established CMR measures with additional newly developed,
        promising, highly refined and clinically applicable quantitative imaging biomarkers, as
        compared to the conventional CMR estimates. Investigators aim to evaluate risk stratification
        and investigate the haemodynamic and morphological changes as well as physical capacity
        before and after interventional or surgical treatment at short and long term.
  
        CMR will be analysed for established imaging biomarkers as well as the potential value of new
        data-driven computer tools searching for new information in the CMR images i.e. shape/texture
        analysis of tissue change, regional haemodynamics, blood flow in relation to metallic
        implants and evaluation of myocardial deformation over time.
  
        CMR measures will be compared to data from echocardiography, catheterization and serological
        markers.
  
        Clinical importance:
  
        If the new refined CMR biomarkers can reveal improved disease characterisation, they may
        reveal feasible in aiding the clinical decision making to optimise timing of intervention and
        predicting long term complications. This could contribute to individualise the treatment and
        improve health in children with CHD. The study may lead to improved patient care and use of
        socio-economical resources.
  observational model: Cohort
  time perspective: Prospective
  measure: CMR measures
  time frame: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
  description: Measurement by CMR of changes in ventricular function, remodelling, tissue characterisation and advanced four dimensional flow (4D-flow) measurements after surgery or intervention
  measure: Physical capacity
  time frame: Before and after 6 months, 1 year and up to 3 years after intervention or surgery
  description: Measurement of physical capacity after surgery or intervention, by cardiopulmonary exercise testing (CPET)
  measure: CMR derived flow measurements near metallic implants, stents
  time frame: after 6 months, 1 year and up to 3 years after intervention
  description: Refined measurements of CMR derived 4D-flow measurements near metallic implants, stents
  arm group label: Aortic valve disease-operation
  description: Surgery of the aortic valve:
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.
  arm group label: Aortic valve disease-intervention
  description: Interventional treatment of the aortic valve:
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.
  arm group label: Pulmonary valve disease-operation
  description: Surgery of the pulmonary valve:
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment.
  arm group label: Pulmonary valve disease-intervention
  description: Interventional treatment of the pulmonary valve:
  Cardiac and blood flow changes assessed by advanced MRI methods before and after treatment
  intervention type: Procedure
  intervention name: Valvuloplasty,
  description: Choice of type of intervention decided on a multidisciplinary conference
  arm group label: Aortic valve disease-intervention
  arm group label: Aortic valve disease-operation
  arm group label: Pulmonary valve disease-intervention
  arm group label: Pulmonary valve disease-operation
  other name: surgical valvular repair
  Whole blood, serum
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Week
  maximum age: 18 Years
  healthy volunteers: No
  last name: Charlotte de Lange, MD, Assoc. Prof
  role: Principal Investigator
  affiliation: Sahlgrenska University hospital, Queen Silvia Childrens' Hospital
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Sahlgrenska University Hospital, Sweden
  investigator full name: Charlotte de Lange
  investigator title: MD PhD, senior consultant
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  mesh term: Aortic Valve Disease
  sharing ipd: Undecided