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Enrolling by invitation NCT07136675

Healthy Adult Reference Biobank for Cardiovascular Biomarkers in China

Observational Healthy Individuals (Controls)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy Individuals (Controls). Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Establishing reference intervals for high-sensitivity cardiac troponin in the apparently healthy population in China.

Detailed description

This study was led by Fuwai Hospital, Chinese Academy of Medical Sciences, and implemented as an observational clinical study in collaboration with multiple centers. It selected residual blood samples from individuals who had undergone physical examinations, had signed informed consent, and had no significant abnormalities in routine laboratory tests. High-sensitivity cardiac troponin was measured to establish reference intervals for cardiovascular biomarkers in the apparently healthy population in China.

Primary outcome measures

  • Detection of high-sensitivity troponin [Time frame: On the day of the physical examination]

Eligibility criteria

Inclusion criteria

Apparent healthy Chinese individuals, aged between 20 and 80 years; Normal electrocardiogram (ECG) during physical examination; Signed informed consent form.

Exclusion criteria

Musculoskeletal disease or a history of rheumatoid arthritis, or high-intensity exercise (e.g., marathon) within the past week; Biotin treatment within the past week; Hospitalization for an emergency within the past three months; Pregnancy or lactation within the past year; Diabetes: fasting blood glucose ≥ 7.0 mmol/L; glycated hemoglobin (HbA1c) ≥ 6.5%; Chronic kidney disease: estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²; Latent heart disease: NT-proBNP > 125 ng/L or BNP > 35 ng/L; Known cardiovascular or heart disease in the past: treated with medication or other interventions; Chronic diseases that may affect the heart (cancer/tumor, autoimmune diseases); Hemolysis, lipemia, or insufficient residual sample volume for testing.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT07136675 · HARBOR Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗