UK CARDIO-IMID registry for heart disease in people with immune-mediated inflammatory conditions
The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry
This registry will see if routine blood heart markers can predict future heart problems in people with immune-mediated inflammatory diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manchester Academic / other |
| Locations | 2 sites (Edinburgh, Scotland and 1 other locations) |
| Trial ID | NCT06478277 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a clinician-diagnosed immune-mediated inflammatory disease, including those classified as higher cardiovascular risk or with new/incident IMID-associated cardiovascular disease, who can give written informed consent are ideal candidates.
Not a fit: People without an IMID diagnosis, those unwilling to provide consent or unable to attend participating UK centres, and those seeking an interventional therapy rather than observational follow-up are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help identify people with IMIDs who are at higher risk of heart disease earlier so care can be tailored to reduce future cardiovascular events.
How similar studies have performed: Cardiac biomarkers like troponin and NT-proBNP have predicted outcomes in general cardiovascular populations, but applying these markers specifically within IMID cohorts is only partly explored and remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Edinburgh, Scotland and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.