Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545799
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou Peoples Hospital
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou Peoples Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None