Cardiovascular DeathNCT06545799
Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital
An observational study of Cardiovascular Death and Myocardial Infarction, run by Jiangsu Taizhou People's Hospital.
Trial summary
1. Participant Recruitment During the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form. 2. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Death, Myocardial Infarction, Stroke
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2034
- How long will I take part?
- 10 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Each year, during the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form.
Who may be able to join
- Employed or retired individuals aged 45 years or older;
- Willing to sign an informed consent form and voluntarily participate in health examinations and related data collection.
Who cannot join
- History of myocardial infarction, ischemic or hemorrhagic stroke, or revascularization of coronary, carotid, or peripheral arteries;
- Employees with severe psychological disorders who are unable to cooperate with the study;
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Participant Recruitment During the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form.
- Screening Phase Medical history is collected, including any previous occurrences of myocardial infarction, ischemic or hemorrhagic stroke, or history of coronary, carotid, or peripheral arterial revascularization.
- Baseline Data Collection
- Health Questionnaire Survey: Collect demographic information, medical history, and data on nutrition, physical activity, and smoking habits through a questionnaire.
- Clinical Assessments: Conduct the following assessments for all enrolled participants:
- High-sensitivity cardiac troponin I and NT-proBNP testing
- Non-invasive arterial stiffness testing
- Measurement of visceral and subcutaneous fat content
- Fundus photography
- Body composition analysis 4 Regular Follow-Up
Read more
Annual follow-up for a total of 10 years. The follow-up includes:
- . Collection of updated demographic information and medical history, as well as repeated questionnaires on nutrition, physical activity, and smoking habits.
- . Reassessment of the following items:
- High-sensitivity cardiac troponin I and NT-proBNP testing
- Non-invasive arterial stiffness testing
- Measurement of visceral and subcutaneous fat content
- Fundus photography
- Body composition analysis 5 Outcome Evaluation
1）. Primary Outcomes: Cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke events.
2）. Secondary Outcomes: All vascular events, changes in cardiovascular biomarkers, and degree of arterial stiffness.
- Conditions
- Cardiovascular Death, Myocardial Infarction, Stroke
- Medical subject headings
- Myocardial Infarction, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke events
Cardiovascular death: Death from heart or blood vessel diseases.
Non-fatal myocardial infarction: Heart attack that does not result in death.
Non-fatal stroke events: Stroke incidents that do not result in death.
Measured: September 2024 to August 2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2034 (estimated)
- Study completion1 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DeathStudies 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545799
- Sponsor's protocol ID
- KY 2024-098-01
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital
- ClinicalTrials.gov ID
- NCT06545799
- Acronym / sponsor ID
- KY 2024-098-01
- Conditions
- Cardiovascular Death, Myocardial Infarction, Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2034 (estimated)
- Study completion
- 1 Sep 2034 (estimated)
- First posted
- 9 Aug 2024 (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.
- Participant Recruitment During the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form.
- Screening Phase Medical history is collected, including any previous occurrences of myocardial infarction, ischemic or hemorrhagic stroke, or history of coronary, carotid, or peripheral arterial revascularization.
- Baseline Data Collection
- Health Questionnaire Survey: Collect demographic information, medical history, and data on nutrition, physical activity, and smoking habits through a questionnaire.
- Clinical Assessments: Conduct the following assessments for all enrolled participants:
- High-sensitivity cardiac troponin I and NT-proBNP testing
- Non-invasive arterial stiffness testing
- Measurement of visceral and subcutaneous fat content
- Fundus photography
- Body composition analysis 4 Regular Follow-Up
Annual follow-up for a total of 10 years. The follow-up includes:
- . Collection of updated demographic information and medical history, as well as repeated questionnaires on nutrition, physical activity, and smoking habits.
- . Reassessment of the following items:
- High-sensitivity cardiac troponin I and NT-proBNP testing
- Non-invasive arterial stiffness testing
- Measurement of visceral and subcutaneous fat content
- Fundus photography
- Body composition analysis 5 Outcome Evaluation
1）. Primary Outcomes: Cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke events.
2）. Secondary Outcomes: All vascular events, changes in cardiovascular biomarkers, and degree of arterial stiffness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Each year, during the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form.
Key inclusion criteria (2 listed)
- Employed or retired individuals aged 45 years or older;
- Willing to sign an informed consent form and voluntarily participate in health examinations and related data collection.
Key exclusion criteria (3 listed)
- History of myocardial infarction, ischemic or hemorrhagic stroke, or revascularization of coronary, carotid, or peripheral arteries;
- Employees with severe psychological disorders who are unable to cooperate with the study;
- Pregnant or breastfeeding women.
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
Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke events
Time frame: September 2024 to August 2034
Cardiovascular death: Death from heart or blood vessel diseases. Non-fatal myocardial infarction: Heart attack that does not result in death. Non-fatal stroke events: Stroke incidents that do not result in death.
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 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Death and Myocardial Infarction, run by Jiangsu Taizhou People's Hospital.
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 2 inclusion and 3 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Qingqing Zhang (+86 180 6198 6120, 18061986120@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke events (time frame: September 2024 to August 2034). 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 9 Aug 2024.