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Clinical Trials/NCT06478277
NCT06478277RecruitingNot Applicable

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

University of Manchester2 sites in 1 country600 target enrollmentStarted: February 4, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
600
Locations
2
Primary Endpoint
Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels

Study Overview

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.

Detailed Description

Multimorbidity is a rapidly growing burden on our healthcare systems, especially with an ageing demographic. CVD is a major cause of morbidity and mortality. The co-association of IMIDs with CVD needs more sophisticated understanding of the underlying risk, earlier identification and tailored use of targeted therapeutics. Importantly, the investigation of CVD in IMID offers an effective human experimental model to improve not just the lives of people with IMIDs but also the general CVD population.

The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) registry will be a key platform for United Kingdom (UK) multi-centre clinical and translational CARDIO-IMID research. The aim is that centres across the UK including all the devolved nations will collaborate and contribute patients such that the registry will provide deep phenotyping, linked to clinical outcomes, in, ultimately, many hundreds of patients. The planned study will establish a deeply phenotyped cohort and/or as part of the optional sub-study, an associated bioresource to support individual discrete studies and/or analyses that address the stated aims and objectives. All potential participants will be invited to participate in the longitudinal collection and evaluation of routine comprehensive clinical information, including pathology, imaging and other cardiovascular data. This programme will identify patients within defined IMID clinical cohorts at different stages of (rheumatology and cardiovascular) disease. These data will be invaluable in enabling a full characterisation of CVD in terms of the extent, presentation, risk factors, and pathophysiology. Patients are seen as per standard clinical practice determined by the index IMID and in this setting, also dependent on co-existing CV comorbidity, usually every 3-6 months at time of IMID/CVD diagnosis and then 6 to 12 monthly thereafter. Specific questionnaires and tests requested outside of standard of care (sub-studies) will depend on disease group and clinical context. Not all patients will be required to complete all the relevant questionnaires, instead, based on individual IMID and/or CVD profile.

In addition, there is the opportunity for subjects to include (i) longitudinal biological (blood) samples and (ii) extended cardiovascular magnetic resonance (CMR) imaging protocol for those receiving CMR as part of National Health Service (NHS) standard of care.

Collectively, the study and associated platform with appropriate biostatistical and machine learning approaches will inform on the pathophysiological sequence of events, identification of prognostic biomarkers and risk models; as well as enable evaluation of the influence of IMID-specific vascular +/- immunosuppressive therapies and traditional cardiac pharmacotherapy where indicated. It will also establish a platform for trials in IMIDs to capture CV outcomes. Moreover, it will provide cohorts of patients readily available for recruitment, with linkage in place for outcomes. It could be used to leverage commercial funding and participation, facilitated by simplified, single-point access for industry. It will enable scaled investigation aimed at understanding causes of CARDIO-IMID, improving risk stratification and providing better care.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • 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)
  • 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

  • Age less than 18 years
  • 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:
  • 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,

Outcomes

Primary Outcomes

Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels

Time Frame: 5 years

The total number of participants with abnormal NT-pro BNP levels (assessed by blood draw) will be measured. Unit: number of participants

Number of participants with abnormal high-sensitivity cardiac troponin I/T levels

Time Frame: 5 years

The total number of participants with abnormal high-sensitivity troponin I/T levels (assessed by blood draw) will be measured. Unit: number of participants

Secondary Outcomes

  • Global longitudinal strain(5 years)
  • Aortic distensibility(5 years)
  • Late gadolinium enhancement(5 years)
  • Number of participants with myopericardial involvement(5 years)
  • Number of participants with atherosclerotic cardiovascular disease (ASCVD)(5 years)
  • Number of participants with other cardiovascular events(5 years)
  • Atrial and ventricular volumetrics(5 years)
  • Systolic and diastolic function(5 years)
  • Abnormalities in regional wall motion(5 years)
  • T1 relaxation time(5 years)
  • T2 relaxation time(5 years)
  • Extracellular volume fraction(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Maya H. Buch

Professor of Rheumatology and Director of Experimental Medicine at the Centre for Musculoskeletal Research, University of Manchester

University of Manchester

Study Sites (2)

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