Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital

NCT ID: NCT06545799

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2034-09-01

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.

Conditions

Cardiovascular Death; Myocardial Infarction; Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Taizhou People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qingqing Zhang

Role: CONTACT

18061986120@189.cn

+86 180 6198 6120

Other Identifiers

KY 2024-098-01

Identifier Type: -

Identifier Source: org_study_id