Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

NCT05982041 | Not Yet Recruiting

• 1 other identifier: IIMCI-1
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Myopathy; Cardiac Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Number of participants with a significant change levels of diagnostic biomarkers

  20 years

• Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls

  20 years

• Incidence of major cardio-vascular events

  20 years

Study Arms (1)

idiopathic inflammatory myopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who had a confirmed or suspected myositis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Myositis; Heart Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Cardiovascular Diseases

Central Study Contacts

Qiang Wang, MD PHD

CONTACT

862568307588; jerrytortoise@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital with Nanjing Medical University

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: August 8, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2043
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share