[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623728":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"patients with calcified lesions",null,"A novel ferumoxytol-enhanced cardiac magnetic resonance imaging and coronary angiography are performed in patients with CCTA proven calcified lesions occupying greater than 50% of the angle of the vascular lumen.",[13],"Drug: Superparamagnetic Iron Oxide Nanoparticles",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Superparamagnetic Iron Oxide Nanoparticles","Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.",[9],[21],"Ferumoxytol",[23],{"name":24,"affiliation":5,"role":25},"Chunjian Li, Phd、MD","PRINCIPAL_INVESTIGATOR",[27,31],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","+86 13701465229","lijay@njmu.edu.cn",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Qin Wang","+86 15651646136","wq_0905@sina.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"First Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],118.77778,32.06167,{"lat":48,"lon":47},[51,52],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},{"type":25,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Chunjian Li","Director of Cardiology",[57],{"name":58,"class":59},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY","100623728","a-novel-ferumoxytol-enhanced-cardiac-magnetic-resonance-for-the-detection-of-calcified-coronary-arteries-100623728",false,"NCT07400406","A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries","Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.","Inclusion Criteria:\n\n1. Age ≥18 years, \\\u003C75 years;\n2. Imaging specialists evaluate CCTA images taken within 30 days and report that calcification occupied one or more of the patient's vascular lumen at an angle of \\>50% (using the coronary artery segmentation method recommended by the American Heart Association, including nine segments of the major branches of the coronary artery);\n3. Patient who will undergo coronary angiography;\n4. Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;\n5. Patient who signs the informed consent.\n\nExclusion Criteria:\n\n1. People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;\n2. Because of psychological (such as suffering from claustrophobic syndrome) or physical reasons (such as the presence of metal objects in the body) can not receive MRI examination;\n3. suffering from terminal diseases (such as malignant tumors) or life expectancy \\\u003C 1 year;\n4. Pregnant or lactating women;\n5. People with limited hearing;\n6. Patients with grade III-IV heart function;\n7. Patients with a history of coronary artery stent implantation or coronary artery bypass;\n8. Other iron agents are being used orally or intravenously;\n9. Patients with hemosiderosis or hemochromatosis;\n10. Patients with acute coronary syndrome;\n11. Patients with hyperthyroidism;\n12. Any other candidates deemed unsuitable by the researchers.","ALL","18 Years","75 Years",{"count":71,"type":72},100,"ESTIMATED","OBSERVATIONAL","This study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions. The purpose of this study was to compare the accuracy of novel Ferumoxytol-enhanced Cardiac Magnetic Resonance (Fe-CMR) and coronary CT angiography (CCTA) in detecting calcified coronary arteries, using coronary angiography (CAG) and optical coherence imaging (OCT) as gold standards.",[76],"Coronary Artery Calcification",[21,78,79,76],"Magnetic Resonance Imaging","Ultrasmall Superparamagnetic Iron Oxide Particles","2026-02-02",{"date":82,"type":83},"2026-02-10","ACTUAL",{"date":85,"type":83},"2024-01-26",{"date":87,"type":72},"2027-08-31",{"name":5,"class":6},1]