[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613113":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":7,"responsibleParty":14,"collaborators":16,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":7,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":31,"maxAge":7,"enrollmentInfo":32,"targetDuration":35,"studyType":36,"phases":7,"briefSummary":37,"conditions":38,"keywords":43,"overallStatus":49,"whyStopped":7,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":7},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Junbo Ge, M.D., Ph.D.","CONTACT","8613816767665","gbge@zs-hospital.sh.cn",{"type":15,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[17,19,21],{"name":18,"class":6},"The First Hospital of Jilin University",{"name":20,"class":6},"Zhongnan Hospital",{"name":22,"class":6},"Fu Wai Hospital, Beijing, China","100613113","intravascular-imaging-evaluated-calcified-nodule-china-registry-100613113",false,"NCT07262359","Intravascular Imaging Evaluated Calcified Nodule China Registry","A Multi-Center, Prospective, Observational Registry for the Evaluation of Coronary Artery Calcified Nodules Using Intravascular Ultrasound (IVUS) and\u002For Optical Coherence Tomography (OCT) in China (CN-IVI Registry)","Inclusion Criteria:\n\n* The patient must be at least 18 years old.\n\nIntracoronary imaging confirms the presence of at least one calcified nodule lesion.\n\nThe patient is willing and able to comply with the study procedures and follow-up until the study concludes.\n\nThe subject confirms understanding of the study's risks, benefits, and alternative treatments, and has signed the informed consent form approved by the ethics committee prior to any protocol-related procedures.\n\nExclusion Criteria:\n\nContraindication to Procedure: Known contraindication to coronary angiography, PCI, or adjunctive pharmacologic therapy (e.g., aspirin, P2Y12 inhibitors, heparin, contrast media) that cannot be adequately managed with standard medical care.\n\nLife Expectancy: Life expectancy of less than 1 year due to non-cardiac comorbid conditions (e.g., active malignancy, advanced organ failure).\n\nInability to Follow-Up: Inability or unwillingness to comply with the study protocol or scheduled follow-up visits.","ALL","18 Years",{"count":33,"type":34},500,"ESTIMATED","3 Years","OBSERVATIONAL","What is this study about? This is a nationwide research study in China focused on understanding a specific type of challenging plaque in heart arteries called a Calcified Nodule (CN). The study will use advanced imaging technology inside the blood vessels to see these nodules in great detail, track how they are treated, and see how patients do in the long term.\n\nWhy is this important? Calcified nodules are hard, bony-like plaques that can cause sudden heart attacks. They are difficult to treat with standard procedures like stenting because they are rigid and can be unpredictable. This registry aims to create a large database of real-world cases to help doctors better understand how to identify and manage CNs effectively, ultimately improving patient care and outcomes across China.\n\nWhat are IVUS and OCT? These are sophisticated imaging tools that doctors use during a heart catheterization. Think of them like a \"GPS\" or an \"ultrasound\" for the inside of your arteries.\n\nIVUS (Intravascular Ultrasound): Uses sound waves to create a detailed, 360-degree picture of the artery wall. It shows the size of the plaque and how deep it goes, helping doctors choose the right size stent.\n\nOCT (Optical Coherence Tomography): Uses light waves to create extremely high-resolution images, like a microscope inside the artery. It is excellent for seeing the precise surface and structure of a calcified nodule.\n\nTogether, these tools give doctors a clear view of the problem, which is crucial for planning the best treatment strategy.\n\nWhat will the study do?\n\nThe registry will collect anonymous data from participating hospitals across China. Researchers will analyze:\n\nHow common calcified nodules are in Chinese patients.\n\nThe best ways to use IVUS and OCT to identify and characterize CNs.\n\nWhich treatment techniques (e.g., special balloons, atherectomy) work best.\n\nThe long-term results for patients who receive stents to treat a CN.\n\nWho is this for?\n\nPatients \\& Families: To understand that advanced care and research are being dedicated to complex heart conditions. Participation (if eligible) contributes to medical knowledge that may help future patients.\n\nHealthcare Providers: To provide a standardized, large-scale analysis of CNs, leading to improved diagnosis, treatment guidelines, and procedural techniques for this complex lesion.\n\nThis registry represents a significant step forward in personalized cardiac care in China, using cutting-edge technology to solve a difficult clinical problem.",[39,40,41,42],"Coronary Artery Disease","Coronary Artery Atherosclerosis","Coronary Calcified Nodules","Coronary Calcification",[44,45,46,47,48],"coronary artery disease","coronary calcification","coronary calcified nodules","optical coherence tomography","intravascular ultrosound","NOT_YET_RECRUITING","2025-11-22",{"date":52,"type":53},"2025-12-03","ACTUAL",{"date":55,"type":34},"2025-12-01",{"date":57,"type":34},"2031-12-01",{"name":5,"class":6}]