Inflammatory MyopathyNCT05982041
Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
An observational study of Inflammatory Myopathy and Cardiac Disease, run by The First Affiliated Hospital with Nanjing Medical University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Myopathy, Cardiac Disease
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2043
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had a confirmed or suspected myositis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Inflammatory Myopathy, Cardiac Disease
- Medical subject headings
- Myositis, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| idiopathic inflammatory myopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 20 years
Secondary outcomes (3)
Number of participants with a significant change levels of diagnostic biomarkers
This will depend on the specific biomarker/cytokine being measured
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
Measured: 20 years
Incidence of major cardio-vascular events
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Jan 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory MyopathyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Qiang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982041
- Sponsor's protocol ID
- IIMCI-1
- Status last verified
- Oct 2023
- First submitted
- 1 Jul 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
- ClinicalTrials.gov ID
- NCT05982041
- Acronym / sponsor ID
- IIMCI-1
- Conditions
- Inflammatory Myopathy, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Jan 2043 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| idiopathic inflammatory myopathy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had a confirmed or suspected myositis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations
Time frame: 20 years
On the basis of the late gadolinium enhancement (LGE) positive by CMR
The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations
Time frame: 20 years
On the basis of extra-cellular volume (ECV) > 30% by CMR
3 secondary outcomes
Number of participants with a significant change levels of diagnostic biomarkers
Time frame: 20 years
Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls
Time frame: 20 years
Incidence of major cardio-vascular events
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Myopathy and Cardiac Disease, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Wang, MD PHD (862568307588, jerrytortoise@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations (time frame: 20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.