Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Myopathy, Cardiac Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
Overview
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.
Primary outcome measures
- The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations [Time frame: 20 years]
- The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations [Time frame: 20 years]
Secondary outcome measures (3)
- Number of participants with a significant change levels of diagnostic biomarkers [Time frame: 20 years]
- Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls [Time frame: 20 years]
- Incidence of major cardio-vascular events [Time frame: 20 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05982041 · IIMCI-1