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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06422572
Other study ID # TJ-IRB202303109
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 30, 2023

Study information

Verified date March 2023
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The results of previous studies were used to assess the causal association between TK levels and stroke occurrence at 5 and 12 years of follow-up, respectively.


Description:

Analyze the data of a 5-year follow-up on 2115 control individuals from the case-control study of the previous research. We completed the 5-year follow-up on this group in 2016 (whether they had a stroke, whether they are alive, and the cause of death). Conduct a 12-year follow-up on 6487 community individuals from the previous study (whether they had a stroke within 12 years, whether they are alive, and the cause of death). We collaborated with the hospital platform's computer center to conduct follow-up through AI questionnaire surveys, followed by supplementing AI questionnaire data with telephone questionnaire surveys for those lost to follow-up. Utilize R language R Studio 4.11 for statistical analysis and plotting. Evaluate the distribution of TK levels in the control group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 5 years. Evaluate the distribution of TK levels in the community group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 12 years.


Recruitment information / eligibility

Status Completed
Enrollment 8602
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 1) Control population in the previous stroke case-control study; - 2) The CHD case-control population in the previous study; - 3) The population in the community cross-sectional study of the previous study. Exclusion Criteria: - Stroke patient

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention
No Intervention

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Qin Zhang National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Stroke The primary outcome measure will be the occurrence of stroke during the 5-year follow-up period. Stroke events will be assessed and recorded based on predetermined diagnostic criteria, such as clinical symptoms, imaging findings, and/or medical records review. The data will be aggregated and reported as the total number of stroke cases observed in the study population. 5 years
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