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NCT05982041
Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
trial in Inflammatory Myopathy in 300 participants. Not yet recruiting.
1 January 2033
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 January 2024 |
| Primary completion | 1 January 2033 |
| Estimated completion | 1 January 2043 |
Conditions studied
- Inflammatory Myopathy — all drugs for Inflammatory Myopathy →
- Cardiac Disease — all drugs for Cardiac Disease →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
18 and older, any sex, with Inflammatory Myopathy or Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05982041
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other The First Affiliated Hospital with Nanjing Medical University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05982041 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 17 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05982041.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing