About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with disease duration >2 years
Patients < 18 years
Confirmed non-inflammatory myopathies
Myositis secondary to alcohol or drug abuse
Trial population
All patients who had a confirmed or suspected myositis
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations
On the basis of the late gadolinium enhancement (LGE) positive by CMR
The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations
On the basis of extra-cellular volume (ECV) \> 30% by CMR
Secondary outcomes
Number of participants with a significant change levels of diagnostic biomarkers
This will depend on the specific biomarker/cytokine being measured
Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls
Specific identified genetic variants will be identified as part of large scale genetic studies
Incidence of major cardio-vascular events
Locations
Sponsors and contacts
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