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Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05982041
Collaborator
(none)
300
Enrollment
232
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2033
    Anticipated Study Completion Date :
    Jan 1, 2043

    Arms and Interventions

    Arm Intervention/Treatment
    idiopathic inflammatory myopathy

    Outcome Measures

    Primary Outcome Measures

    1. cardiac injury in the different myositis subgroups based on radiological evaluations [20 years]

      On the basis of the late gadolinium enhancement (LGE) positive, and extra-cellular volume (ECV) > 30% by CMR

    Secondary Outcome Measures

    1. Number of participants with a significant change levels of diagnostic biomarkers [20 years]

      This will depend on the specific biomarker/cytokine being measured

    2. Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls [20 years]

      Specific identified genetic variants will be identified as part of large scale genetic studies

    3. Incidence of major cardio-vascular events [20 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance imaging) or suspected clinically myositis

    • Age over 18 years old

    • Signature of the informed consent form for the study

    Exclusion Criteria:

    • Patients with disease duration >2 years

    • Patients < 18 years

    • Confirmed non-inflammatory myopathies

    • Myositis secondary to alcohol or drug abuse

    • Patients unwilling or unable to give consent

    • Patients with poor or no venous access

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital with Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wang Qiang, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital with Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT05982041
    Other Study ID Numbers:
    • IIMCI-1
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Muscular Diseases
    Myositis
    Heart Diseases

    Study Results

    No Results Posted as of Aug 8, 2023