Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Cardiac Disease Clinical Trial

Official title:

A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05982041
• Other study ID #: IIMCI-1
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Inflammatory Myopathy
• Muscular Diseases
• Myositis

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