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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07033624

Enrollment

10000

Registered

2025-06-24

Start date

2025-07-01

Completion date

2047-07-01

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Cardiovascular death	2 years	Cardiovascular death
All-cause death	2 years	All-cause death
Myocardial infarction	2 years	Myocardial infarction
Stroke	2 years	Stroke

Countries

China

Contacts

Primary ContactHaibo Jia, MD

jhb101180@163.com15945685291_

Outcome results