Healthy Adult Reference Biobank for Cardiovascular Biomarkers in China

NCT ID: NCT07136675

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-22

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Individuals (Controls)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HARBOR Study

Identifier Type: -

Identifier Source: org_study_id

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