[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552837":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":57,"studyPopulation":58,"armGroups":53,"interventions":53,"overallOfficials":59,"centralContacts":63,"locations":72,"responsibleParty":112,"collaborators":115,"id":136,"slug":53,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":53,"enrollmentInfo":145,"targetDuration":148,"studyType":149,"phases":53,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":75,"whyStopped":53,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"University of Manchester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":53},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with abnormal high-sensitivity cardiac troponin I\u002FT levels","The total number of participants with abnormal high-sensitivity troponin I\u002FT levels (assessed by blood draw) will be measured.\n\nUnit: number of participants","5 years",{"measure":14,"description":15,"timeFrame":12},"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.\n\nUnit: number of participants",[17,20,23,26,29,32,35,38,41,44,47,50],{"measure":18,"description":19,"timeFrame":12},"Number of participants with atherosclerotic cardiovascular disease (ASCVD)","Total number of participants with ASCVD\n\nASCVD: 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.\n\nUnit: number of participants",{"measure":21,"description":22,"timeFrame":12},"Number of participants with myopericardial involvement","Total number of participants with primary myocardial events such as myocarditis, pericarditis.\n\nUnits: number of participants",{"measure":24,"description":25,"timeFrame":12},"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\u002For pulmonary embolism \\[PE\\], all-cause mortality).\n\nUnits: number of participants",{"measure":27,"description":28,"timeFrame":12},"Atrial and ventricular volumetrics","Atrial and ventricular volumetrics will be continuously measured. Mean and median values will be reported.\n\nUnits: mL\u002Fm2",{"measure":30,"description":31,"timeFrame":12},"Systolic and diastolic function","Systolic and diastolic function will be continuously measured. Mean values will be reported.\n\nUnits: %",{"measure":33,"description":34,"timeFrame":12},"Abnormalities in regional wall motion","Abnormalities in regional wall motion will be reported as a descriptive measure.\n\nUnit: 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))",{"measure":36,"description":37,"timeFrame":12},"Global longitudinal strain","Global longitudinal strain will be continuously measured. Mean values will be reported.\n\nUnits: %",{"measure":39,"description":40,"timeFrame":12},"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.\n\nUnit: ms",{"measure":42,"description":43,"timeFrame":12},"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.\n\nUnit: no units (reported as either: presence or absence)",{"measure":45,"description":46,"timeFrame":12},"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.\n\nUnit: ms",{"measure":48,"description":49,"timeFrame":12},"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.\n\nUnit: %",{"measure":51,"description":52,"timeFrame":12},"Aortic distensibility","Aortic distensibility will be continuously measured in participants undergoing cardiac magnetic resonance imaging. Mean and median values will be reported.\n\nUnit: mm\u002FHg",null,{"allocation":53,"interventionModel":53,"interventionModelDescription":53,"primaryPurpose":53,"observationalModel":55,"timePerspective":56,"maskingInfo":53},"COHORT","PROSPECTIVE","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.\n\nThe 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\u002For as part of the optional sub-study, an associated bioresource to support individual discrete studies and\u002For 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\u002FCVD 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\u002For CVD profile.\n\nIn 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.\n\nCollectively, 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 +\u002F- 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.","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.",[60],{"name":61,"affiliation":5,"role":62},"Maya H Buch, MD","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":53,"email":68},"Georgia Reeves","CONTACT","+44 161 306 5600","georgia.reeves@manchester.ac.uk",{"name":70,"role":66,"phone":67,"phoneExt":53,"email":71},"James Lawrence","james.lawrence@manchester.ac.uk",[73,95],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Royal Infirmary of Edinburgh","RECRUITING","Edinburgh","Scotland","EH16 4SA","United Kingdom","UK",{"type":82,"coordinates":83},"Point",[84,85],-3.19648,55.95206,{"lat":85,"lon":84},[88,91,94],{"name":89,"role":66,"phone":53,"phoneExt":53,"email":90},"Hannah Castello","hannah.costello@ed.ac.uk",{"name":92,"role":66,"phone":53,"phoneExt":53,"email":93},"Marc Dweck","marc.dweck@ed.ac.uk",{"name":92,"role":62,"phone":53,"phoneExt":53,"email":53},{"facility":96,"status":75,"city":97,"state":53,"zip":98,"country":79,"countryCode":80,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Countess of Chester Hospital NHS Foundation Trust","Chester","CH2 1UL",{"type":82,"coordinates":100},[101,102],-2.89189,53.1905,{"lat":102,"lon":101},[105,108,111],{"name":106,"role":66,"phone":53,"phoneExt":53,"email":107},"Judith Prince","jude.prince@nhs.net",{"name":109,"role":66,"phone":53,"phoneExt":53,"email":110},"Theresa Barnes","theresa.barnes@nhs.net",{"name":109,"role":62,"phone":53,"phoneExt":53,"email":53},{"type":62,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Prof. Maya H. Buch","Professor of Rheumatology and Director of Experimental Medicine at the Centre for Musculoskeletal Research, University of Manchester",[116,118,120,122,124,126,129,131,133],{"name":117,"class":6},"University of Cambridge",{"name":119,"class":6},"University of Oxford",{"name":121,"class":6},"University of Edinburgh",{"name":123,"class":6},"University of Leeds",{"name":125,"class":6},"Imperial College London",{"name":127,"class":128},"Medical Research Council","OTHER_GOV",{"name":130,"class":6},"British Heart Foundation",{"name":132,"class":6},"Swansea University",{"name":134,"class":135},"British Heart Foundation Data Science Centre","UNKNOWN","100552837",false,"NCT06478277","UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study","The UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry","CARDIO-IMID","Inclusion Criteria:\n\n1. Written informed consent\n2. Diagnosis of an IMID by a rheumatologist with categorisation into one of the following:\n\n   i. IMID-'higher risk' CVD: individuals who have a risk of developing CVD (based on traditional risk factors and\u002For IMID-specific factors) but no history of CVD\n   1. Coronary artery disease (CAD): specifically, a high pre-test probability of CAD based on clinical risk factors (e.g. QRISK3 score ≥10%) and\u002For elevated biochemical markers (high-sensitivity C-reactive protein ≥2mg\u002FL and\u002For Lipoprotein(a) ≥70mg\u002FdL)\n   2. Myopericardial involvement: Specific IMID and\u002For 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\u002For NT-pro BNP), on routine testing\n\n      ii. Incident (new) IMID-CVD: Patients with IMID that present with a new history of CVD\n\n   \u003C!-- -->\n\n   1. ASCVD i. Major adverse cardiovascular events (MACE):\n\n      \\- Non-fatal myocardial infarction.\n\n      \\- Non-fatal stroke of any classification, including reversible focal neurologic\n\n      \\- Defects with imaging evidence of a new cerebral lesion consistent with ischemia or haemorrhage.\n\n      ii. Other cardiovascular events not accounted for in the MACE-3 composite 2)a)i:\n\n      \\- Hospitalization for unstable angina\n\n      \\- Coronary revascularization\n\n      \\- Hospitalization for heart failure\n\n      \\- Transient Ischemic Attack (TIA)\n\n      \\- Peripheral Vascular Disease (PVD)\n      * Deep vein thrombosis (VTE) and\u002For pulmonary embolism \\[PE\\].\n   2. Myopericardial involvement: as diagnosed by a cardiology specialist with 'tier 2' cardiovascular imaging and\u002For other clinical and biochemical criteria in line with usual care\n\n      iii. Established IMID-CVD\n\n   a) Patients with IMID and a history of past cardiovascular event as detailed in 2) a) above.\n\n   b) Patients with a known history of myopericardial involvement as defined above in 2) b)\n\nBiological sub-study inclusion criteria\n\n* There are no additional inclusion criteria for this sub-study\n\nExtended protocol standard CMR sub-study inclusion criteria.\n\n* Participants that receive a CMR scan as standard of care\n\nExclusion Criteria:\n\n1. Age less than 18 years\n2. Unable to give informed consent\n\nBiological sub-study exclusion criteria:\n\n\\- There are no additional exclusion criteria for this sub-study\n\nCMR sub-study exclusion criteria:\n\nStandard of care contraindications to:\n\n1. CMR: metal implant eg metal fragments in the eye, pacemaker; claustrophobia; inability to lie flat\n2. Magnetic Resonance Imaging (MRI) contrast: renal failure with estimated glomerular filtration rate (eGFR) \\\u003C30,","ALL","18 Years",{"count":146,"type":147},600,"ESTIMATED","5 Years","OBSERVATIONAL","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\u002Fpathology and investigations) in patients across the IMIDs. Optional biological and\u002For imaging sub-studies will provide additional data and\u002For samples for associated analyses.",[152,153],"Cardiovascular Diseases","Immune-Mediated Inflammatory Diseases",[155,156,157],"Cardiovascular disease","Immune-mediated Inflammatory Diseases","Registry","2026-02-04",{"date":160,"type":161},"2026-02-06","ACTUAL",{"date":158,"type":161},{"date":164,"type":147},"2028-08",{"name":5,"class":6},2]