UK CARDIO-IMID registry for heart disease in people with immune-mediated inflammatory conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CARDIO-IMID registry is a UK multi-centre program that will collect detailed clinical, pathology, imaging, and outcome data from people with immune-mediated inflammatory diseases (IMIDs). Participants will be followed longitudinally with linkage to routine cardiovascular investigations and outcomes to create a deeply phenotyped cohort. Optional sub-studies will collect biological samples and additional imaging for more detailed translational analyses. The dataset will be a platform for collaborative clinical and translational research across centres in the United Kingdom.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent
2. 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
   1. 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)
   2. 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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   1. 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 \[PE\].
   2. 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)

Biological sub-study inclusion criteria

* There are no additional inclusion criteria for this sub-study

Extended protocol standard CMR sub-study inclusion criteria.

* Participants that receive a CMR scan as standard of care

Exclusion Criteria:

1. Age less than 18 years
2. Unable to give informed consent

Biological sub-study exclusion criteria:

\- There are no additional exclusion criteria for this sub-study

CMR sub-study exclusion criteria:

Standard of care contraindications to:

1. CMR: metal implant eg metal fragments in the eye, pacemaker; claustrophobia; inability to lie flat
2. Magnetic Resonance Imaging (MRI) contrast: renal failure with estimated glomerular filtration rate (eGFR) \<30,

Where it's running

• Royal Infirmary of Edinburgh
  Edinburgh, Scotland, United Kingdom Recruiting
• Countess of Chester Hospital NHS Foundation Trust
  Chester, United Kingdom Recruiting

Study contacts

• Principal investigator: Maya H Buch, MD — University of Manchester
• Study coordinator: Georgia Reeves
• Email: georgia.reeves@manchester.ac.uk
• Phone: +44 161 306 5600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.