NCT06478277 UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study
| NCT ID | NCT06478277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2026-02-04 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 <!-- --> 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,
Contact & Investigator
Maya H Buch, MD
PRINCIPAL INVESTIGATOR
University of Manchester
Frequently Asked Questions
Who can join the NCT06478277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06478277 currently recruiting?
Yes, NCT06478277 is actively recruiting participants. Contact the research team at georgia.reeves@manchester.ac.uk for enrollment information.
Where is the NCT06478277 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom, Chester, United Kingdom.
Who is sponsoring the NCT06478277 clinical trial?
NCT06478277 is sponsored by University of Manchester. The principal investigator is Maya H Buch, MD at University of Manchester. The trial plans to enroll 600 participants.