Cardiovascular DiseasesNCT07033624
Cardiovascular Risk Early Screening and Warning in Harbin : A Prospective Cohort Study
An observational study of Cardiovascular Diseases, run by Harbin Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2047
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Haibo Jia, MD, 15945685291, jhb101180@163.com
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular diseases, microbiome, genomics, metabolism, imaging, risk prediction
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event (MACE)
A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke
Measured: 2 years
Secondary outcomes (4)
Cardiovascular death
Cardiovascular death
Measured: 2 years
All-cause death
All-cause death
Measured: 2 years
Myocardial infarction
Myocardial infarction
Measured: 2 years
Stroke
Stroke
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033624
- Sponsor's protocol ID
- KY2025-042
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Early Screening and Warning in Harbin : A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07033624
- Acronym / sponsor ID
- KY2025-042
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular diseases, microbiome, genomics, metabolism, imaging, risk prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2047 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular event (MACE)
Time frame: 2 years
A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke
4 secondary outcomes
Cardiovascular death
Time frame: 2 years
All-cause death
Time frame: 2 years
Myocardial infarction
Time frame: 2 years
Stroke
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haibo Jia, MD (15945685291_, jhb101180@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular event (MACE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.