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

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT07033624
• Lead Sponsor: Harbin Medical University

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.

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2047-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event (MACE)	2 years	A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke

Secondary Outcome Measures

Name	Time	Method
All-cause death	2 years	All-cause death
Myocardial infarction	2 years	Myocardial infarction
Stroke	2 years	Stroke
Cardiovascular death	2 years	Cardiovascular death

Trial Locations

Locations (1)

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China