Clinical trial NCT06545799: Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital
Official title: Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Death
Myocardial Infarction
Stroke
Lead sponsor: Jiangsu Taizhou People's Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.
3. Baseline Data Collection

1. Health Questionnaire Survey: Collect demographic information, medical history, and data on nutrition, physical activity, and smoking habits through a questionnaire.

2. 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:

1. . Collection of updated demographic information and medical history, as well as repeated questionnaires on nutrition, physical activity, and smoking habits.
2. . 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.


Eligibility criteria: Inclusion Criteria:

1. Employed or retired individuals aged 45 years or older;
2. Willing to sign an informed consent form and voluntarily participate in health examinations and related data collection.

Exclusion Criteria:

1. History of myocardial infarction, ischemic or hemorrhagic stroke, or revascularization of coronary, carotid, or peripheral arteries;
2. Employees with severe psychological disorders who are unable to cooperate with the study;
3. Pregnant or breastfeeding women.

Primary outcomes:
measure: Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke events
timeFrame: September 2024 to August 2034
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: