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NCT Number: NCT07033624

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location contact

Haibo Jia, MD

CONTACT

[email protected]

15945685291

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Major adverse cardiovascular event (MACE)

    Time frame: 2 years

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

Secondary outcomes

  1. Cardiovascular death

    Time frame: 2 years

    Cardiovascular death

  2. All-cause death

    Time frame: 2 years

    All-cause death

  3. Myocardial infarction

    Time frame: 2 years

    Myocardial infarction

  4. Stroke

    Time frame: 2 years

    Stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Haibo Jia, MD

CONTACT

[email protected]

15945685291_

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2047
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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