Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: idiopathic inflammatory myopathy

Trial outcomes

Primary outcomes

1

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

Time frame
20 years
2

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

Time frame
20 years

Secondary outcomes

1

Number of participants with a significant change levels of diagnostic biomarkers

This will depend on the specific biomarker/cytokine being measured

Time frame
20 years
2

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

Time frame
20 years
3

Incidence of major cardio-vascular events

Time frame
20 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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