NCT06545799

Brief Summary

  • 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
102mo left

Started Sep 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Sep 2024Sep 2034

First Submitted

Initial submission to the registry

July 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2034

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

10 years

First QC Date

July 30, 2024

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    September 2024 to August 2034

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 ml of blood

MeSH Terms

Conditions

Myocardial InfarctionStroke

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 9, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2034

Study Completion (Estimated)

September 1, 2034

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share