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NCT05982041

Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Not yet recruiting Last updated 17 October 2023
What this trial tests

trial in Inflammatory Myopathy in 300 participants. Not yet recruiting.

Timeline
1 January 2024
Primary endpoint
1 January 2033
1 January 2043

Quick facts

Lead sponsorThe First Affiliated Hospital with Nanjing Medical University
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment300
Start date1 January 2024
Primary completion1 January 2033
Estimated completion1 January 2043

Conditions studied

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

18 and older, any sex, with Inflammatory Myopathy or Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Inflammatory Myopathy

Currently open trials in the same condition.

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

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Data sources for this page

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