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

NCT07033624 | Not Yet Recruiting

• 1 other identifier: KY2025-042
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular diseases, microbiome, genomics, metabolism, imaging, risk prediction

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular event (MACE)

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

  2 years

Secondary Outcomes (4)

• Cardiovascular death

  2 years

• All-cause death

  2 years

• Myocardial infarction

  2 years

• Stroke

  2 years

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Haibo Jia, MD

CONTACT

15945685291_; jhb101180@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiology Department, the 2nd Affiliated Hospital of Harbin Medical University

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2047
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)