Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Not yet recruiting

• Conditions: Inflammatory Myopathy; Cardiac Disease

• Registration Number: NCT05982041
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-01
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17
• Study Start: 2024-01-01
• Primary Completion: 2033-01-01
• Study Completion: 2043-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations	20 years	On the basis of extra-cellular volume (ECV) \> 30% by CMR
The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations	20 years	On the basis of the late gadolinium enhancement (LGE) positive by CMR

Secondary Outcome Measures

Name	Time	Method
Number of participants with a significant change levels of diagnostic biomarkers	20 years	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	20 years	Specific identified genetic variants will be identified as part of large scale genetic studies
Incidence of major cardio-vascular events	20 years