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NCT Number: NCT05982041

Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations

    Time frame: 20 years

    On the basis of the late gadolinium enhancement (LGE) positive by CMR

  2. The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations

    Time frame: 20 years

    On the basis of extra-cellular volume (ECV) > 30% by CMR

Secondary outcomes

  1. Number of participants with a significant change levels of diagnostic biomarkers

    Time frame: 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

    Time frame: 20 years

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

  3. Incidence of major cardio-vascular events

    Time frame: 20 years

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Wang, MD PHD

CONTACT

[email protected]

862568307588

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Important dates

Study start
2024
Primary completion
2033
Study completion
2043
First posted
Aug 8, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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