NCT06963619尚未招募不适用
NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China
研究概览
简要总结
To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet all the following criteria are eligible for inclusion:
- •Voluntarily participate in this study and sign informed consent;
- •Body Mass Index (BMI) ≥18.5 and <28kg/ m2;
- •Age ≥18 years old;
- •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").
排除标准
- •Subjects who meet any of the following criteria will be excluded:
- •Physical examination, laboratory test/examination results meet any of the following:
- •eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney disease epidemiology collaboration) < 60 mL/min/1.732
- •Systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mmHg
- •Glycated hemoglobin A1c (HbA1c) ≥ 6.0%; or fasting blood glucose ≥ 7.0 mmol/L
- •Total cholesterol ≥ 6.22 mmol/L and/or triglycerides ≥ 2.26 mmol/L
- •High-sensitivity troponin: Female: ≥15.6 pg/mL (ng/L), Male: ≥34.2 pg/mL (ng/L)
- •Electrocardiogram, with obvious abnormalities such as those that may cause cardiac structural changes or risk factors for arrhythmia as assessed by the investigator
- •Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;
- •Subjects who withdraw informed consent;
- •Subjects assessed by the investigator as unsuitable for inclusion in this study.
结局指标
主要结局
AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China
时间窗: 12 months
To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.
次要结局
未报告次要终点
研究者
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