Healthy Adult Reference Biobank for Cardiovascular Biomarkers in China

NCT07136675 | Enrolling By Invitation

• 1 other identifier: HARBOR Study
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Individuals (Controls)

Keywords

Healthy population, high-sensitivity troponin

Outcome Measures

Primary Outcomes (1)

• Detection of high-sensitivity troponin

  High-sensitivity troponin, establishment of reference intervals

  On the day of the physical examination

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy population

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100050, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 22, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)