UK CARDIO-IMID Study v1.0 22Jul2024

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    341045

  • Contact name

    Stacey Body

  • Contact email

    fbmhethics@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Clinicaltrials.gov Identifier

    NCT06478277

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    4 years, 0 months, 30 days

  • Research summary

    We would like to know more about cardiovascular abnormalities in patients with immune-mediated inflammatory diseases (IMID) with the aim to provide new biomarkers (clinical, blood, imaging) for early diagnosis, prognosis and prediction of cardiovascular disease (CVD) in patients with IMID. This is important as there are still many unknowns in this area, and finding out more could improve how patients are treated in future.

    Participants with IMID diagnoses will be recruited from rheumatology/cardiology departments as in-patients or out-patients and categorised into one of the following: IMID-‘at 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, Incident (new) IMID-CVD (patients with IMID who present with a new history of CVD, or Established IMID-CVD (patients with IMID and history of previous CVD). Once consented, researchers will collect past, present and future clinical information about them, including routine cardiovascular imaging and blood tests. Participants will also be asked to complete questionnaires at predetermined intervals. Data will be collected over 5 years at 6 and then 12 month intervals (based on individual clinical need). Participants may also take part in the following sub-studies; Biological sub-study, in which additional blood samples will be collected at standard care visits; and the Imaging-sub study, in which Cardiovascular Magnetic Resonance Imaging (CMR) will be performed. CMR will only be conducted as part of routine standard care, with an additional 10 minutes of scanning to obtain further information.

    This study is funded by the Medical Research Council Populations & Systems Medicine Biology Board (with co-funding from the British Heart Foundation). The UK registry, detailed in this protocol, is one of several activities and initiatives planned and supported by the grant (hosted by the University of Manchester). The study will recruit in specialist NHS centres across the UK.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    24/LO/0645

  • Date of REC Opinion

    16 Oct 2024

  • REC opinion

    Further Information Favourable Opinion