[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590146":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":8,"collaborators":7,"id":10,"slug":7,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":7,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":7,"enrollmentInfo":18,"targetDuration":7,"studyType":21,"phases":7,"briefSummary":22,"conditions":23,"keywords":7,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":7},{"fullName":5,"class":6},"Radiometer Medical ApS","INDUSTRY",null,{"type":9,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100590146",false,"NCT06963619","AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Reference Interval Study Protocol - China","NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol","Inclusion Criteria:\n\nSubjects who meet all the following criteria are eligible for inclusion:\n\n1. Voluntarily participate in this study and sign informed consent;\n2. Body Mass Index (BMI) ≥18.5 and \\\u003C28kg\u002F m2;\n3. Age ≥18 years old;\n4. Through the investigator's consultation with the subjects, evaluate the subjects who meet the requirements of the reference individual of this study (refer to the \"reference individual questionnaire\").\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Physical examination, laboratory test\u002Fexamination results meet any of the following:\n\n   * eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney disease epidemiology collaboration) \\\u003C 60 mL\u002Fmin\u002F1.732\n   * Systolic blood pressure ≥130 mm Hg and\u002For diastolic blood pressure ≥80 mmHg\n   * Glycated hemoglobin A1c (HbA1c) ≥ 6.0%; or fasting blood glucose ≥ 7.0 mmol\u002FL\n   * Total cholesterol ≥ 6.22 mmol\u002FL and\u002For triglycerides ≥ 2.26 mmol\u002FL\n   * High-sensitivity troponin: Female: ≥15.6 pg\u002FmL (ng\u002FL), Male: ≥34.2 pg\u002FmL (ng\u002FL)\n   * Electrocardiogram, with obvious abnormalities such as those that may cause cardiac structural changes or risk factors for arrhythmia as assessed by the investigator\n2. Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;\n3. Subjects who withdraw informed consent;\n4. Subjects assessed by the investigator as unsuitable for inclusion in this study.","ALL","18 Years",{"count":19,"type":20},240,"ESTIMATED","OBSERVATIONAL","To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.",[24],"Diagnostic Tests","NOT_YET_RECRUITING","2025-05-06",{"date":28,"type":29},"2025-05-09","ACTUAL",{"date":31,"type":20},"2025-05",{"date":33,"type":20},"2025-12",{"name":5,"class":6}]