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/NCT05982041</url>
    </required_header>
    <id_info>
      <org_study_id>IIMCI-1</org_study_id>
      <nct_id>NCT05982041</nct_id>
    </id_info>
    <brief_title>Adult Idiopathic Inflammatory Myopathy With Cardiac Injury</brief_title>
    <official_title>A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical University</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>
        Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be&#xD;
        recruited. Patients will be approached, consented, have baseline demographics, diagnostics&#xD;
        and disease activity measures recorded, and blood taken. The collection of data and&#xD;
        biological material will mirror usual clinical practice as far as possible. Subjects will&#xD;
        ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures&#xD;
        recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging&#xD;
        undertaken as part of usual care will also be collected for research purposes to measure a&#xD;
        number of biomarkers for the assessment of diagnostic accuracy and clinical utility&#xD;
        evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a&#xD;
        further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR)&#xD;
        muscle protocol will also be performed as per usual clinical practice, and a&#xD;
        gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months.&#xD;
        An existing electronic database entry system will be used for data entry and capture on an&#xD;
        anonymised basis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2043</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2033</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>30 Years</target_duration>
    <primary_outcome>
      <measure>cardiac injury in the different myositis subgroups based on radiological evaluations</measure>
      <time_frame>20 years</time_frame>
      <description>On the basis of the late gadolinium enhancement (LGE) positive, and extra-cellular volume (ECV) &gt; 30% by CMR</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with a significant change levels of diagnostic biomarkers</measure>
      <time_frame>20 years</time_frame>
      <description>This will depend on the specific biomarker/cytokine being measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls</measure>
      <time_frame>20 years</time_frame>
      <description>Specific identified genetic variants will be identified as part of large scale genetic studies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of major cardio-vascular events</measure>
      <time_frame>20 years</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Inflammatory Myopathy</condition>
    <condition>Cardiac Disease</condition>
    <arm_group>
      <arm_group_label>idiopathic inflammatory myopathy</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          All patients who had a confirmed or suspected myositis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance&#xD;
               imaging) or suspected clinically myositis&#xD;
  &#xD;
            -  Age over 18 years old&#xD;
  &#xD;
            -  Signature of the informed consent form for the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with disease duration &gt;2 years&#xD;
  &#xD;
            -  Patients &lt; 18 years&#xD;
  &#xD;
            -  Confirmed non-inflammatory myopathies&#xD;
  &#xD;
            -  Myositis secondary to alcohol or drug abuse&#xD;
  &#xD;
            -  Patients unwilling or unable to give consent&#xD;
  &#xD;
            -  Patients with poor or no venous access&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qiang Wang, MD PHD</last_name>
      <phone>862568307588</phone>
      <email>jerrytortoise@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Wang Qiang</investigator_full_name>
      <investigator_title>The First Affiliated Hospital with Nanjing Medical University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscular Diseases</mesh_term>
      <mesh_term>Myositis</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/NCT05982041
  org study id: IIMCI-1
  nct id: NCT05982041
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be
        recruited. Patients will be approached, consented, have baseline demographics, diagnostics
        and disease activity measures recorded, and blood taken. The collection of data and
        biological material will mirror usual clinical practice as far as possible. Subjects will
        ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures
        recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging
        undertaken as part of usual care will also be collected for research purposes to measure a
        number of biomarkers for the assessment of diagnostic accuracy and clinical utility
        evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a
        further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR)
        muscle protocol will also be performed as per usual clinical practice, and a
        gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months.
        An existing electronic database entry system will be used for data entry and capture on an
        anonymised basis.
  observational model: Cohort
  time perspective: Prospective
  measure: cardiac injury in the different myositis subgroups based on radiological evaluations
  time frame: 20 years
  description: On the basis of the late gadolinium enhancement (LGE) positive, and extra-cellular volume (ECV) > 30% by CMR
  measure: Number of participants with a significant change levels of diagnostic biomarkers
  time frame: 20 years
  description: This will depend on the specific biomarker/cytokine being measured
  measure: Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls
  time frame: 20 years
  description: Specific identified genetic variants will be identified as part of large scale genetic studies
  measure: Incidence of major cardio-vascular events
  time frame: 20 years
  arm group label: idiopathic inflammatory myopathy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Qiang Wang, MD PHD
  phone: 862568307588
  email: jerrytortoise@163.com
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
  investigator full name: Wang Qiang
  investigator title: The First Affiliated Hospital with Nanjing Medical University
  mesh term: Muscular Diseases
  mesh term: Myositis
  mesh term: Heart Diseases
  sharing ipd: No