Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Disease; Inflammatory Myopathy

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Qiang Wang, MD PHD; Phone Number: 862568307588; Email: jerrytortoise@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who had a confirmed or suspected myositis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
idiopathic inflammatory myopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2043

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Heart Diseases; Muscular Diseases; Myositis
• Other Study ID Numbers: IIMCI-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No