RecruitingNCT06478277

UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study

The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry


Sponsor

University of Manchester

Enrollment

600 participants

Start Date

Feb 4, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to develop a large, deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular (CV) disease (CVD) and Immune-mediated-inflammatory-diseases (IMID). The main aim is to evaluate whether existing blood cardiac biomarkers predict adverse cardiovascular outcomes. The study will capture standard of care CV and associated health data (clinical, biochemistry/pathology and investigations) in patients across the IMIDs. Optional biological and/or imaging sub-studies will provide additional data and/or samples for associated analyses.


Eligibility

Min Age: 18 Years

Inclusion Criteria23

  • Written informed consent
  • Diagnosis of an IMID by a rheumatologist with categorisation into one of the following:
  • i. IMID-'higher risk' CVD: individuals who have a risk of developing CVD (based on traditional risk factors and/or IMID-specific factors) but no history of CVD
  • Coronary artery disease (CAD): specifically, a high pre-test probability of CAD based on clinical risk factors (e.g. QRISK3 score ≥10%) and/or elevated biochemical markers (high-sensitivity C-reactive protein ≥2mg/L and/or Lipoprotein(a) ≥70mg/dL)
  • Myopericardial involvement: Specific IMID and/or cardiovascular indicators that place at increased risk e.g. autoantibody associations, presence of peripheral myositis or other major organ involvement; incidental raised serum cardiac biomarkers (troponin and/or NT-pro BNP), on routine testing
  • ii. Incident (new) IMID-CVD: Patients with IMID that present with a new history of CVD
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  • ASCVD i. Major adverse cardiovascular events (MACE):
  • \- Non-fatal myocardial infarction.
  • \- Non-fatal stroke of any classification, including reversible focal neurologic
  • \- Defects with imaging evidence of a new cerebral lesion consistent with ischemia or haemorrhage.
  • ii. Other cardiovascular events not accounted for in the MACE-3 composite 2)a)i:
  • \- Hospitalization for unstable angina
  • \- Coronary revascularization
  • \- Hospitalization for heart failure
  • \- Transient Ischemic Attack (TIA)
  • \- Peripheral Vascular Disease (PVD)
  • Deep vein thrombosis (VTE) and/or pulmonary embolism \[PE\].
  • Myopericardial involvement: as diagnosed by a cardiology specialist with 'tier 2' cardiovascular imaging and/or other clinical and biochemical criteria in line with usual care
  • iii. Established IMID-CVD
  • a) Patients with IMID and a history of past cardiovascular event as detailed in 2) a) above.
  • b) Patients with a known history of myopericardial involvement as defined above in 2) b)
  • Participants that receive a CMR scan as standard of care

Exclusion Criteria5

  • Age less than 18 years
  • Unable to give informed consent
  • Standard of care contraindications to:
  • CMR: metal implant eg metal fragments in the eye, pacemaker; claustrophobia; inability to lie flat
  • Magnetic Resonance Imaging (MRI) contrast: renal failure with estimated glomerular filtration rate (eGFR) <30,

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Locations(2)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Countess of Chester Hospital NHS Foundation Trust

Chester, United Kingdom

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NCT06478277


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