[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420993":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":50,"armGroups":45,"interventions":51,"overallOfficials":45,"centralContacts":56,"locations":65,"responsibleParty":83,"collaborators":85,"id":96,"slug":45,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":45,"enrollmentInfo":105,"targetDuration":45,"studyType":108,"phases":45,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":68,"whyStopped":45,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Leicester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"1. Diagnostic performance of CMR and CT-FFR","Diagnostic accuracy of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence\u002Fabsence of significant coronary artery disease at the subject level when compared with invasive FFR.","6 weeks",[14,16,19,22,25,28,32,35,39,42],{"measure":10,"description":15,"timeFrame":12},"1\\. Sensitivity and specificity of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence\u002Fabsence of significant coronary artery disease at the subject level when compared with invasive FFR.",{"measure":17,"description":18,"timeFrame":12},"2. Diagnostic performance of CMR and CT-FFR","2\\. Diagnostic accuracy, sensitivity and specificity of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence\u002Fabsence of significant coronary artery disease at the vessel level when compared with invasive FFR.",{"measure":20,"description":21,"timeFrame":12},"3. Diagnostic performance of CMR T1 mapping","Diagnostic accuracy, sensitivity and specificity of CMR T1 mapping using invasive FFR as the reference standard (per patient and per vessel levels).",{"measure":23,"description":24,"timeFrame":12},"4. Diagnostic performance of hybrid imaging","Diagnostic accuracy, sensitivity and specificity of hybrid CMR\u002FCT-FFR using invasive FFR as the reference standard (per patient and per vessel levels).",{"measure":26,"description":27,"timeFrame":12},"Diagnostic performance of strain assessment","5\\. Diagnostic accuracy, sensitivity and specificity of CMR strain assessment (global\u002Fsegmental longitudinal\u002Fcircumferential strain, mechanical dispersion) using invasive FFR as the reference standard (per patient and per vessel levels).",{"measure":29,"description":30,"timeFrame":31},"6. Cost analysis","Cost analysis to assess the long term costs of the different diagnostic testing strategies. Healthcare costs for each testing strategy - data on resource use (staff time, scan duration, hospital days and clinic visits) will be collected during the study period.","2 years",{"measure":33,"description":34,"timeFrame":31},"7. Clinical endpoints","Prediction by imaging modalities of clinical endpoints (subsequent percutaneous and\u002For surgical revascularisation, admissions with acute coronary syndrome and cerebrovascular accident, all-cause mortality).",{"measure":36,"description":37,"timeFrame":38},"8. Subjective experience","Subjective patient scan experience for CMR and CTCA.","1 day",{"measure":40,"description":41,"timeFrame":38},"9. Time duration of each scan\u002Fscan component.","Duration of each scan\u002Fscan component.",{"measure":43,"description":44,"timeFrame":38},"10. Image quality","Image quality of each scan\u002Fscan component, assessed visually on a 4-point score - excellent (3), good (2), moderate (1) and poor (0).",null,{"allocation":45,"interventionModel":45,"interventionModelDescription":45,"primaryPurpose":45,"observationalModel":47,"timePerspective":48,"maskingInfo":45},"COHORT","PROSPECTIVE","In patients with suspected coronary artery disease (CAD), CT coronary angiography (CTCA) provides excellent sensitivity and negative predictive value, enabling the safe exclusion of significant CAD. However, its positive predictive value remains suboptimal (c.50%). Undertaking additional CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. It has been established that CMR perfusion imaging offers excellent diagnostic accuracy for the identification of functionally significant coronary artery disease. The diagnostic performance of qualitative CMR perfusion assessment may be further enhanced by additional quantitative assessment. The purpose of this prospective observational study is to evaluate the diagnostic performance of all three modalities (CT-FFR and qualitative and quantitative CMR perfusion imaging), involving 300 patients with suspected coronary artery disease referred for invasive coronary angiography. A subset of 167 subjects will undergo an additional accelerated CMR scan for comparison. Invasively measured fractional flow reserve (FFR) will serve as the reference standard.","Patients with suspected coronary artery disease referred for invasive coronary angiography",[52],{"type":53,"name":54,"description":55,"armGroupLabels":45,"otherNames":45},"DIAGNOSTIC_TEST","CMR and CTCA with CT-FFR","multi-parametric CMR assessment and CT coronary angiography with FFR assessment",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":45,"email":61},"Jayanth Arnold","CONTACT","0300 303 1573","jra14@le.ac.uk",{"name":63,"role":59,"phone":45,"phoneExt":45,"email":64},"Mo Elshibly","mmme1@le.ac.uk",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Glenfield Hospital","RECRUITING","Leicester","Leics","LE3 (QP","United Kingdom","UK",{"type":75,"coordinates":76},"Point",[77,78],-1.13169,52.6386,{"lat":78,"lon":77},[81,82],{"name":58,"role":59,"phone":60,"phoneExt":45,"email":61},{"name":63,"role":59,"phone":60,"phoneExt":45,"email":64},{"type":84,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[86,89,92,94],{"name":87,"class":88},"HeartFlow, Inc.","INDUSTRY",{"name":90,"class":91},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":93,"class":6},"University of Oxford",{"name":95,"class":6},"University of Glasgow","100420993",false,"NCT04761991","CMR Versus CT in Coronary Artery Disease","Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease","CONCORD","Inclusion Criteria:\n\n* Patients aged ≥18 years\n* Referred for invasive coronary angiography for investigation of chest pain\n\nExclusion Criteria:\n\n* Recent acute coronary syndrome (\\\u003C 6 months)\n* Previous coronary artery bypass grafting\n* Severe claustrophobia\n* Absolute contraindications to CMR - those with MR conditional or safe devices will be included\n* Second-\u002Fthird-degree atrioventricular block\n* Severe chronic obstructive pulmonary disease\n* Moderate-severe asthma\n* Estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Women who are pregnant, breast-feeding or of child-bearing potential( premenopausal women)\n* Contraindication to iodinated contrast\n* Participation in a research study involving an investigational product in the past 12 weeks","ALL","18 Years",{"count":106,"type":107},300,"ESTIMATED","OBSERVATIONAL","CONCORD is a prospective observational study evaluating the diagnostic accuracy of cardiovascular magnetic resonance (CMR) and computed tomography with fractional flow reserve (CT-FFR) in patients with suspected coronary artery disease, using invasive fractional flow reserve (FFR) as the reference standard.",[111],"Coronary Artery Disease",[113,114,115],"MRI","CT-FFR","coronary artery disease","2025-06-26",{"date":118,"type":119},"2025-07-01","ACTUAL",{"date":121,"type":119},"2020-11-05",{"date":123,"type":107},"2025-11-30",{"name":5,"class":6},1]