An observational study in Inflammatory Myopathy and Cardiac Disease, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 111 observational studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who had a confirmed or suspected myositis
Exclusion Criteria:
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
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
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
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
Incidence of major cardio-vascular events
Time frame: 20 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital with Nanjing Medical University