UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study
NCT Number: NCT06478277
Acronym: CARDIO-IMID
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Immune-Mediated Inflammatory Diseases
Sponsor: University of Manchester
Collaborators: University of Cambridge|University of Oxford|University of Edinburgh|University of Leeds|Imperial College London|Medical Research Council|British Heart Foundation|Swansea University|British Heart Foundation Data Science Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2028-07

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.

Primary Outcome Measures: Number of participants with abnormal high-sensitivity cardiac troponin I/T levels, 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, 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: Number of participants with atherosclerotic cardiovascular disease (ASCVD), 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, 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, 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, Atrial and ventricular volumetrics will be continuously measured. Mean and median values will be reported.

Units: mL/m2, 5 years|Systolic and diastolic function, Systolic and diastolic function will be continuously measured. Mean values will be reported.

Units: %, 5 years|Abnormalities in regional wall motion, 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, Global longitudinal strain will be continuously measured. Mean values will be reported.

Units: %, 5 years|T2 relaxation time, 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, 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, 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, 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, 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