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

February 4, 2026 updated by: Prof. Maya H. Buch, University of Manchester

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with atherosclerotic cardiovascular disease (ASCVD)
Time Frame: 5 years

Total number of participants with ASCVD

ASCVD: Death due to acute myocardial infarction (MI), Sudden cardiac death, Death due to heart failure, Death due to stroke, Death due to cardiovascular procedures, Death due to cardiovascular haemorrhage, Death due to other cardiovascular causes: peripheral artery disease, Non-fatal MI, Non-fatal stroke of any classification, including reversible focal neurologic, defects with imaging evidence of a new cerebral lesion consistent with ischemia or haemorrhage.

Unit: number of participants
5 years
Number of participants with myopericardial involvement
Time Frame: 5 years

Total number of participants with primary myocardial events such as myocarditis, pericarditis.

Units: number of participants
5 years
Number of participants with other cardiovascular events
Time Frame: 5 years

The total number of participants with other cardiovascular events not already accounted for: Hospitalization for unstable angina; Coronary revascularization; Hospitalization for heart failure; Transient ischemic attack (TIA); Peripheral vascular disease (PVD); Venous thromboembolism (VTE) (deep vein thrombosis and/or pulmonary embolism [PE], all-cause mortality).

Units: number of participants
5 years
Atrial and ventricular volumetrics
Time Frame: 5 years

Atrial and ventricular volumetrics will be continuously measured. Mean and median values will be reported.

Units: mL/m2
5 years
Systolic and diastolic function
Time Frame: 5 years

Systolic and diastolic function will be continuously measured. Mean values will be reported.

Units: %
5 years
Abnormalities in regional wall motion
Time Frame: 5 years

Abnormalities in regional wall motion will be reported as a descriptive measure.

Unit: no units (descriptive measure of either: normal, hypokinetic (reduced endocardial excursion and wall thickening), akinetic (absent endocardial excursion and wall thickening) or diskinetic (systolic bulging with no thickening))
5 years
Global longitudinal strain
Time Frame: 5 years

Global longitudinal strain will be continuously measured. Mean values will be reported.

Units: %
5 years
T2 relaxation time
Time Frame: 5 years

T2 relaxation time will be continuously measured in participants undergoing cardiac magnetic resonance imaging as an indicator of myocardial inflammation. Mean and median values will be reported.

Unit: ms
5 years
Late gadolinium enhancement
Time Frame: 5 years

Late gadolinium enhancement will be measured in participants undergoing cardiac magnetic resonance imaging as an indicator for the presence and extent of replacement fibrosis.

Unit: no units (reported as either: presence or absence)
5 years
T1 relaxation time
Time Frame: 5 years

T1 relaxation time will be continuously measured in participants undergoing cardiac magnetic resonance imaging as an indicator for the presence and extent of replacement fibrosis. Mean and median values will be reported.

Unit: ms
5 years
Extracellular volume fraction
Time Frame: 5 years

Extracellular volume fraction will be continuously measured in participants undergoing cardiac magnetic resonance imaging as an indicator for the presence and extent of replacement fibrosis. Mean values will be reported.

Unit: %
5 years
Aortic distensibility
Time Frame: 5 years

Aortic distensibility will be continuously measured in participants undergoing cardiac magnetic resonance imaging. Mean and median values will be reported.

Unit: mm/Hg
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

Imperial College London
University of Leeds
Medical Research Council
University of Oxford
University of Edinburgh
University of Cambridge
Swansea University
British Heart Foundation
British Heart Foundation Data Science Centre

Investigators

  • Principal Investigator: Maya H Buch, MD, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known as to whether individual participant data (IPD) will be made available, as data will be released upon approval of application to the executive steering committee to release cohort data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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