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Not yet recruiting NCT07033624

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

Observational Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Major adverse cardiovascular event (MACE) [Time frame: 2 years]
Secondary outcome measures (4)
  • Cardiovascular death [Time frame: 2 years]
  • All-cause death [Time frame: 2 years]
  • Myocardial infarction [Time frame: 2 years]
  • Stroke [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Second Affiliated Hospital of Harbin Medical University — Harbin

Identifiers

NCT: NCT07033624 · KY2025-042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗