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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05982041
Other study ID # IIMCI-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date January 1, 2043

Study information

Verified date October 2023
Source The First Affiliated Hospital with Nanjing Medical University
Contact Qiang Wang, MD PHD
Phone 862568307588
Email jerrytortoise@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date January 1, 2043
Est. primary completion date January 1, 2033
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of participants with a significant change levels of diagnostic biomarkers This will depend on the specific biomarker/cytokine being measured 20 years
Secondary 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
Secondary Incidence of major cardio-vascular events 20 years
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