UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
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
Deep vein thrombosis (VTE) and/or pulmonary embolism [PE].
Disqualifiers
Age less than 18 years
Unable to give informed consent
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,
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
5 years2
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
Time frame
5 yearsSecondary outcomes
1
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
Time frame
5 years2
Number of participants with myopericardial involvement
Total number of participants with primary myocardial events such as myocarditis, pericarditis. Units: number of participants
Time frame
5 years3
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
Time frame
5 years4
Atrial and ventricular volumetrics
Atrial and ventricular volumetrics will be continuously measured. Mean and median values will be reported. Units: mL/m2
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manchester
Lead sponsor
University of Cambridge
Collaborator
University of Oxford
Collaborator
University of Edinburgh
Collaborator
University of Leeds
Collaborator
Imperial College London
Collaborator
Medical Research Council
Collaborator
British Heart Foundation
Collaborator
Swansea University
Collaborator
British Heart Foundation Data Science Centre
Collaborator
Source ClinicalTrials.gov