Healthy Individuals (Controls)HARBORNCT07136675
Healthy Adult Reference Biobank for Cardiovascular Biomarkers in China
An observational study of Healthy Individuals (Controls), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Establishing reference intervals for high-sensitivity cardiac troponin in the apparently healthy population in China. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals (Controls)
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy population
Who may be able to join
- Apparent healthy Chinese individuals, aged between 20 and 80 years; Normal electrocardiogram (ECG) during physical examination; Signed informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100050
About this study
Establishing reference intervals for high-sensitivity cardiac troponin in the apparently healthy population in China.
Read the 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.
- Conditions
- Healthy Individuals (Controls)
- Keywords
- Healthy population, high-sensitivity troponin
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of high-sensitivity troponin
High-sensitivity troponin, establishment of reference intervals
Measured: On the day of the physical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start22 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Individuals (Controls)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136675
- Sponsor's protocol ID
- HARBOR Study
- Acronym
- HARBOR
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Adult Reference Biobank for Cardiovascular Biomarkers in China
- ClinicalTrials.gov ID
- NCT07136675
- Acronym / sponsor ID
- HARBOR / HARBOR Study
- Conditions
- Healthy Individuals (Controls)
- Keywords
- Healthy population, high-sensitivity troponin
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy population
Key inclusion criteria (1 listed)
- Apparent healthy Chinese individuals, aged between 20 and 80 years; Normal electrocardiogram (ECG) during physical examination; Signed informed consent form.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of high-sensitivity troponin
Time frame: On the day of the physical examination
High-sensitivity troponin, establishment of reference intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals (Controls), run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of high-sensitivity troponin (time frame: On the day of the physical examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.