[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656277":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":26,"overallOfficials":26,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":78,"studyType":79,"phases":26,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Beijing Chao Yang Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of major adverse cardiovascular events (MACE)","Incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and hospitalization for unstable angina requiring urgent revascularization, stratified by the presence versus absence of PCCT-defined high-risk plaque.","Up to 24 months",[14,17],{"measure":15,"description":16,"timeFrame":12},"Per-lesion MACE","Per-lesion hazard ratio of MACE for PCCT-defined HRP and OCT-defined HRP, adjusted for baseline clinical risk factors",{"measure":18,"description":19,"timeFrame":12},"Myocardial infarction","Time to first non-fatal myocardial infarction",[21],{"measure":22,"description":23,"timeFrame":24},"Diagnostic accuracy of PCCT for detecting OCT-defined high-risk plaque","per-patient and per-lesion sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve","up to 12 month",{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":27,"timePerspective":28,"maskingInfo":26},null,"COHORT","PROSPECTIVE","Photon-Counting Detector CT (PCCT) enables improved spatial resolution and spectral tissue characterization, allowing non-invasive detection of high-risk coronary plaque (HRP) features such as low-attenuation plaque (\\\u003C30 HU), positive remodeling (index ≥1.1), spotty calcification, and the napkin-ring sign. The presence of ≥2 of these features defines a PCCT-detected high-risk plaque. Optical Coherence Tomography (OCT), an invasive high-resolution imaging tool, defines HRP by thin-cap fibroatheroma (fibrous cap thickness \\\u003C65 μm, lipid arc \\>90°) and other vulnerable features. While OCT provides detailed information on plaque vulnerability, it is invasive and limited to selected vessels. The prognostic significance of PCCT-defined HRP, and its diagnostic agreement with OCT, remain to be fully established.\n\nThis prospective, single-centre study will enroll patients with acute or stable coronary syndromes who are scheduled for clinically indicated invasive coronary angiography and OCT evaluation of at least one native coronary artery. All participants will first undergo a dedicated contrast-enhanced PCCT coronary angiogram. Within 30 days after PCCT, participants will undergo invasive coronary angiography with OCT imaging. Thus, OCT is systematically acquired after the CT, allowing a cross-sectional diagnostic comparison where PCCT findings are evaluated against the OCT reference. Both imaging datasets will be analyzed by independent core laboratories blinded to each other's results and to clinical data.\n\nThe study has two integrated components:\n\n1. Prognostic component - The primary objective is to assess whether the presence of PCCT-defined HRP independently predicts the 2-year incidence of MACE (cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina requiring urgent revascularization). The primary hypothesis is that MACE rate is significantly higher in patients with PCCT-HRP than in those without.\n2. Cross-sectional diagnostic comparison - Using OCT as the invasive reference, the diagnostic performance of PCCT for identifying high-risk plaque will be determined. Per-patient and per-lesion sensitivity, specificity, positive and negative predictive values, and overall accuracy of PCCT will be calculated and compared with OCT-derived high-risk plaque classification.\n\nParticipants will be followed prospectively for MACE and unplanned revascularization over 24 months.","Patient with coronary artery disease",[32,35],{"label":33,"type":26,"description":34,"interventionNames":26},"PCCT High-Risk Plaque Group","Participants with PCCT-defined high-risk plaque in at least one native coronary artery. High-risk plaque is defined as the presence of ≥2 of the following features on PCCT: low-attenuation plaque (\\\u003C30 Hounsfield Units), positive remodeling (remodeling index ≥1.1), spotty calcification (\\\u003C3 mm), and the napkin-ring sign.",{"label":36,"type":26,"description":37,"interventionNames":26},"PCCT Non-High-Risk Plaque Group","Participants without PCCT-defined high-risk plaque (0 or 1 high-risk feature) in any imaged coronary segment.",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Bin Tu, MD.PhD","CONTACT","+8618810682692","dr_bintu@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":49,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Beijing Chaoyang Hospital，Capital Medical University, Beijing","RECRUITING","Beijing","China","10000","CN",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":42,"phoneExt":26,"email":43},"Bin Tu, MD, PhD",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Lin Zhao","Chief of the Cardia department","100656277","pcct-defined-high-risk-plaque-and-future-coronary-events-the-predict-study-100656277",false,"NCT07822737","PCCT-Defined High-Risk Plaque and Future Coronary Events: The PREDICT Study","Prognostic Value of Photon-Counting Detector CT-Derived High-Risk Coronary Plaque Features for Predicting Major Adverse Cardiovascular Events: a Prospective Cohort Study","PREDICT","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled for clinically indicated, non-emergent invasive coronary angiography\n* Provision of written informed consent and willingness to comply with long-term follow-up\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate \\\u003C45 mL\u002Fmin\u002F1.73 m²\n* Known allergy to iodinated contrast media\n* Pregnancy or breastfeeding\n* Persistent atrial fibrillation or other arrhythmia precluding adequate ECG-gated CT acquisition\n* Body mass index \\>40 kg\u002Fm²\n* Target vessel with a previously implanted stent\n* Life expectancy \\\u003C2 years or any condition that, in the opinion of the investigator, makes follow-up unlikely or participation inappropriate","ALL","18 Years",{"count":76,"type":77},500,"ESTIMATED","2 Years","OBSERVATIONAL","This prospective cohort study aims to determine whether high-risk coronary plaques identified by novel Photon-Counting Detector CT (PCCT) independently predict future major adverse cardiovascular events (MACE). Participants will be followed for MACE and revascularization. The primary hypothesis is that the incidence of MACE is significantly higher in patients with PCCT-defined high-risk plaque than in those without. Additionally, patients will undergo Optical Coherence Tomography (OCT) and angiography within a month after PCCT; PCCT results will be compared with OCT in a cross-sectional analysis, and diagnostic performance will be evaluated against follow-up data.",[82,83,84],"Coronary Artery Disease","Plaque","Photon-Counting Computed Tomography",[84,82,86],"High risk plaque","2026-09-14",{"date":89,"type":90},"2026-09-16","ACTUAL",{"date":92,"type":90},"2025-01-18",{"date":94,"type":77},"2030-12-30",{"name":5,"class":6},1]