Status:
NOT_YET_RECRUITING
AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Reference Interval Study Protocol - China
Lead Sponsor:
Radiometer Medical ApS
Conditions:
Diagnostic Tests
Eligibility:
All Genders
18+ years
Brief Summary
To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.
Eligibility Criteria
Inclusion
- 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").
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06963619
Start Date
May 1 2025
End Date
December 1 2025
Last Update
May 9 2025
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