Healthy Adult Reference Biobank for Cardiovascular Biomarkers in China

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07136675

Acronym

HARBOR

Enrollment

2400

Registered

2025-08-22

Start date

2025-04-22

Completion date

2026-12-31

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Individuals (Controls)

Keywords

Healthy population, high-sensitivity troponin

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Detection of high-sensitivity troponin	On the day of the physical examination	High-sensitivity troponin, establishment of reference intervals

Countries

China

Outcome results