New registry aims to uncover heart risks in inflammatory disease patients
NCT ID NCT06478277
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is building a large group of 600 people with immune-mediated inflammatory diseases (like arthritis or lupus) to track their heart health over time. Researchers will use simple blood tests to see if certain heart-related markers can predict future heart problems. The goal is to better understand and manage cardiovascular risks in these patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this registry could help doctors better predict heart problems in people with inflammatory diseases, leading to earlier prevention.
- What could go wrong
- This is an observational study, not a treatment trial. It collects data but does not test any intervention, so it cannot directly improve health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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,
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Countess of Chester Hospital NHS Foundation Trust
RECRUITINGChester, CH2 1UL, United Kingdom
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Royal Infirmary of Edinburgh
RECRUITINGEdinburgh, Scotland, EH16 4SA, United Kingdom
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