[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562251":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":65,"collaborators":10,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":81,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":10,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Manchester","OTHER",[8,12,14,17,20,23,26,29],{"label":9,"type":10,"description":11,"interventionNames":10},"Disease Control (IMID and no CV disease)",null,"Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also.\n\nWhere indicated, two groups of disease control patients will be recruited: (i) patients with an IMID and no CV disease and (ii) patients with CVD and no IMID diagnosis.\n\nThe following assessments will be conducted (if indicated as part of a participants standard care):\n\nClinician Questionnaires\n\nClinical\u002Fmedical, health and social care and social determinants\n\nRoutine laboratory assessments\n\nRoutine cardiovascular imaging and electrophysiology assessments\n\nInvestigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care\n\nRoutine peripheral vascular imaging assessment\n\nPatient reported outcome measures (PROMs) Questionnaires",{"label":13,"type":10,"description":11,"interventionNames":10},"Disease Control (CV disease and no IMID)",{"label":15,"type":10,"description":16,"interventionNames":10},"Healthy Control (no IMID history or CV disease)","Control subjects will be asked to consent to a limited routine clinical, laboratory and imaging assessment and separate consent will be sought for imaging and biological sample collection. Consent for genetic (DNA) sample collection will be sought separately also.\n\nHealthy Control participants will have a limited number of assessments performed which may include:\n\n* Demographics, employment\n* Medical history, diagnoses, co-morbidities, symptoms, signs, lifestyle (smoking status (pack years) and alcohol intake (units\u002Fweek), CVD risk scores\n* Detailed family history of autoimmune, vascular and rheumatic disease\n* Medications, vaccinations\n* Physical status (e.g. height and weight, blood pressure), IMID disease activity assessment as indicated\n* Data on hospital attendances and admissions, MACE, death registry information.",{"label":18,"type":10,"description":19,"interventionNames":10},"Main Study (IMID 'at risk' CVD)","Individuals who have a risk of developing CVD (based on traditional risk factors and\u002For IMID-specific factors) but no history of major adverse cardiovascular events (MACE).\n\nThe main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD).\n\nThe following assessments will be conducted (if indicated as part of a participants standard care):\n\nClinician Questionnaires\n\nClinical\u002Fmedical, health and social care and social determinants\n\nRoutine laboratory assessments\n\nRoutine cardiovascular imaging and electrophysiology assessments\n\nInvestigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care\n\nRoutine peripheral vascular imaging assessment\n\nPatient reported outcome measures (PROMs) Questionnaires",{"label":21,"type":10,"description":22,"interventionNames":10},"Main Study (Incident (new) IMID-CVD)","Patients with IMID that present with a MACE.\n\nThe main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD).\n\nThe following assessments will be conducted (if indicated as part of a participants standard care):\n\nClinician Questionnaires\n\nClinical\u002Fmedical, health and social care and social determinants\n\nRoutine laboratory assessments\n\nRoutine cardiovascular imaging and electrophysiology assessments\n\nInvestigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care\n\nRoutine peripheral vascular imaging assessment\n\nPatient reported outcome measures (PROMs) Questionnaires",{"label":24,"type":10,"description":25,"interventionNames":10},"Main Study (Established IMID-CVD)","Patients with IMID and a history of previous MACE.\n\nThe main study represents standard clinical care and includes the routine clinical, laboratory and imaging assessments. Patients may be recruited at any point along their CVD continuum (eg when considered at risk, at time of or after a diagnosis of a CVD).\n\nThe following assessments will be conducted (if indicated as part of a participants standard care):\n\nClinician Questionnaires\n\nClinical\u002Fmedical, health and social care and social determinants\n\nRoutine laboratory assessments\n\nRoutine cardiovascular imaging and electrophysiology assessments\n\nInvestigations to evaluate for cardiac conduction abnormalities and arrythmia may also be performed as part of routine care\n\nRoutine peripheral vascular imaging assessment\n\nPatient reported outcome measures (PROMs) Questionnaires",{"label":27,"type":10,"description":28,"interventionNames":10},"Imaging Sub-Study","In addition to the main study, patients will be offered the opportunity to consent to participate in the imaging Sub-Study.\n\nPatients consenting to the Imaging Sub-Study must also have consented to participate in the Main Study. Assessments conducted as part of the Main Study are outlined in the relevant 'Main Study' Group\u002FCohort descriptions.\n\nIndividuals participating in the Imaging Sub-Study may be asked to undergo additional imaging tests above standard of care (undertaken separately to the main study assessments\u002Fvisits) using dedicated research protocols.\n\nThe following assessments may be conducted:\n\nEchocardiography\n\nCardiovascular Magnetic Resonance Imaging (CMR)\n\nPeripheral vascular imaging techniques:\n\nLaser Doppler Imaging (LDI) and laser speckle contrast imaging (LSCI)\n\nNailfold capillaroscopy\n\nMultispectral imaging\n\nNon-vascular skin imaging techniques:\n\nHigh frequency ultrasound",{"label":30,"type":10,"description":31,"interventionNames":10},"Biological Sub-Study","In addition to the Main Study, patients will be offered the opportunity to consent to participate in the Biological Sub-Study.\n\nPatients consenting to the Biological Sub-Study must also have consented to participate in the Main Study. Assessments conducted as part of the Main Study are outlined in the relevant 'Main Study' Group\u002FCohort descriptions.\n\nBiological samples as part of the Sub-Study are in addition to standard of care blood samples.\n\nA maximum of 75mls of blood may be taken to enable the range of experimental studies. The samples may be taken at initial time of recruitment (baseline) and\u002For may be repeated at certain time points depending on the diagnosis and if a change in the clinical status (excluding genotyping).\n\nThe blood may be drawn into a combination of EDTA, lithium heparin, red clotted, citrate and PAXGENE\u002FTEMPUS tubes, according to planned experiments at each time point.",[33],{"name":34,"affiliation":5,"role":35},"Maya H Buch, MD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"James Lawrence, MSc","CONTACT","+44 161 306 5679","james.lawrence@manchester.ac.uk",{"name":34,"role":39,"phone":10,"phoneExt":10,"email":43},"maya.buch@manchester.ac.uk",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Manchester University NHS Foundation Trust","RECRUITING","Manchester","Greater Manchester","M13 9WL","United Kingdom","UK",{"type":54,"coordinates":55},"Point",[56,57],-2.23743,53.48095,{"lat":57,"lon":56},[60,63],{"name":61,"role":39,"phone":10,"phoneExt":10,"email":62},"Abbie Edwards","abbie.edwards@mft.nhs.uk",{"name":64,"role":35,"phone":10,"phoneExt":10,"email":10},"Maya H Buch, PhD",{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Maya H. Buch","Professor of Rheumatology and Director of Experimental Medicine at the Centre for Musculoskeletal Research, University of Manchester","100562251","greater-manchester-cardiovascular-pathology-in-immune-mediated-inflammatory-diseases-100562251",false,"NCT06600737","Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases","GM CARDIO-IMID","Main Study\n\nInclusion Criteria:\n\n* Males and females\n* Subjects aged over 18 years\n* Capable of providing informed consent and signing a consent form\n* Have a clear diagnosis of an IMID with history consistent with one of the following categories:\n* IMID-'at risk' CVD: individuals who have a risk of developing CVD (based on traditional risk factors and\u002For IMID-specific factors) but no history of major adverse cardiovascular events (MACE).\n* Incident (new) IMID-CVD: Patients with IMID that present with a MACE.\n* Established IMID-CVD: Patients with IMID and a history of previous MACE\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Lack of capacity to give informed consent\n\nImaging Sub-Study\n\nInclusion Criteria:\n\n\\- As-listed for Main Study\n\nExclusion Criteria:\n\n* As-listed for Main Study and;\n* For the research cardiac MRI imaging component, the following exclusions will apply: pacemakers, surgical clips within the head, certain inner ear implants, neuro-electrical stimulators or metal fragments within the eye or head, pregnancy or breast-feeding. For administration of gadolinium-based contrast agent, GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2 is a contraindication.\n\nBiological Sub-Study\n\nInclusion Criteria:\n\n\\- As-listed for Main Study\n\nExclusion Criteria:\n\n\\- As-listed for Main Study\n\nControls\n\nInclusion Criteria:\n\n* Subject ≥ 18 years of age\n* Is capable of understanding and signing an informed consent form\n* No known diagnosis of an IMID (CVD-no IMID disease control and healthy control groups)\n* No known diagnosis of CVD (IMID-no risk CVD disease control and healthy control groups)\n\nExclusion Criteria:\n\n* As-listed for Main Study and;\n* For the research cardiac MRI imaging component, the following exclusions will apply: pacemakers, surgical clips within the head, certain inner ear implants, neuro-electrical stimulators or metal fragments within the eye or head, pregnancy or breast-feeding. For administration of gadolinium-based contrast agent, GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2 is a contraindication.\n\nFor Healthy controls:\n\nThe researchers will aim to identify healthy controls using the 'bring a friend' strategy where the patient is asked to bring a friend\u002Frelative, thus minimising demographic bias. This will establish a healthy control pool. For specific analyses, controls will be age and sex matched and where possible, BMI-matched to the specific study population.",true,"ALL","18 Years",{"count":79,"type":80},325,"ESTIMATED","10 Years","OBSERVATIONAL","The researchers would like to know more about cardiovascular abnormalities in patients with immune-mediated inflammatory diseases (IMID) and with the aim to provide new biomarkers (clinical, blood, imaging) for early diagnosis, prognosis and prediction of CVD in patients with IMID. This is important as there are still many things that are not known about this and finding out more could improve how patients are treated in future.\n\nParticipants with IMID diagnoses will be recruited from rheumatology\u002Fcardiology departments as in-patients or outpatients.\n\nOnce 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. The participants could also be approached to take part in the following sub-studies; Biological sub-study, in which blood and urine would be collected; And the Imaging-sub study, in which one or more of Echocardiography, Cardiovascular Magnetic Resonance Imaging (CMR) and Laser Doppler Imaging (LDI) will be performed. Participants with CVD without IMID and healthy volunteers will also be recruited as comparison groups.\n\nThe research is to be funded by the NIHR Manchester BRC ('Integrated Cardiovascular' and 'Rheumatic \\& Musculoskeletal Diseases' themes). Other funding eg Manchester Academic Health Sciences and a recently awarded Medical Research Council Partnership grant will also support this programme. The study will recruit in specialist NHS centres; Recruitment will start in Manchester University Hospitals NHS Foundation Trust.",[85,86],"Cardiovascular Diseases","Rheumatologic Disease","2024-09-17",{"date":89,"type":90},"2024-09-19","ACTUAL",{"date":92,"type":80},"2024-09-30",{"date":94,"type":80},"2032-09-01",{"name":5,"class":6},1]