Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Myopathy, Cardiac Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| idiopathic inflammatory myopathy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 20 years | 
| 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 | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a significant change levels of diagnostic biomarkers | This will depend on the specific biomarker/cytokine being measured | 20 years | 
| 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 | 20 years | 
| Incidence of major cardio-vascular events |  | 20 years |