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Not yet recruitingNCT07033624Updated Jun 24, 2025

Cardiovascular Risk Early Screening and Warning in Harbin : A Prospective Cohort Study

An observational study in Cardiovascular Diseases, sponsored by Harbin Medical University. Not yet recruiting at 1 site in China. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Harbin Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
45 Years and older
Sex
All
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Study summary

The aim of this prospective cohort study is to collect the multi-omics profile of cardiovascular disease (CVD) high-risk individuals in Harbin, and to discover novel biomarker signatures of major adverse cardiovascular events (MACE) during a minimum 2-year follow-up period.

Read the detailed description

This is a single-center, observational, prospective cohort study. The primary endpoint is the incidence of MACE. Participants must meet at least two of the following criteria: hypertension, hyperglycemia, hyperlipidemia, or obesity. Baseline data and biological samples will be collected at enrollment, with clinical outcomes monitored for a minimum of two years. The study aims to enroll 10,000 participants aged 45 years and older from Harbin city, located in northeastern China.

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Conditions studied

  • Cardiovascular Diseases

Keywords

  • Cardiovascular diseases, microbiome, genomics, metabolism, imaging, risk prediction
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study will enroll 10,000 participants aged 45 and above from Harbin, a city in northeastern China. To be eligible, participants must meet at least two of the following criteria: hypertension, hyperglycemia, hyperlipidemia, or obesity.

Inclusion criteria

  • 1.Residents of Harbin city, regardless of gender.
  • 2.Meets at least two of the following conditions: diabetes, hypertension, hyperlipidemia, or obesity.
  • 3.No history of cardiovascular or cerebrovascular diseases.
  • 4.Willing to participate in the study and sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  • 1.History of antibiotic or probiotic treatment within the past month.
  • 2. Pregnant women.
  • 3. History of autoimmune diseases or malignant tumors; severe heart, liver, or kidney dysfunction; or a history of severe cardiovascular or cerebrovascular diseases.
  • 4. Any unstable condition or situation that may jeopardize patient safety or compliance.
  • 5. Patients unable to provide informed consent due to physical reasons or unwilling to participate.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular event (MACE)

    A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke

    Time frame: 2 years

Secondary outcomes

  1. Cardiovascular death

    Cardiovascular death

    Time frame: 2 years

  2. All-cause death

    All-cause death

    Time frame: 2 years

  3. Myocardial infarction

    Myocardial infarction

    Time frame: 2 years

  4. Stroke

    Stroke

    Time frame: 2 years

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Study locations

1 site
  • The Second Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07033624
Lead sponsor
Harbin Medical University
Responsible party
Yu Bo (Director, Cardiology Department, the 2nd Affiliated Hospital of Harbin Medical University, Harbin Medical University) — Principal investigator
First posted
Jun 24, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2047 (estimated)
Last update
Jun 24, 2025

Study contacts

Haibo Jia, MD
Contact
jhb101180@163.com
15945685291_

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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