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

NCT ID: NCT07033624

Last Updated: 2025-06-24

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

NOT_YET_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2047-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yu Bo

Director, Cardiology Department, the 2nd Affiliated Hospital of Harbin Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

Central Contacts

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Haibo Jia, MD

Role: CONTACT

15945685291_

Facility Contacts

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Haibo Jia, MD

Role: primary

15945685291

Other Identifiers

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KY2025-042

Identifier Type: -

Identifier Source: org_study_id

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