Tissue Kallikrein Protect Against Ischemic Stroke

Completed

• Conditions: Stroke, Ischemic
• Interventions: Other: No Intervention

• Registration Number: NCT06422572
• Lead Sponsor: Qin Zhang

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-05-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-18
• Last Update Submitted: 2024-05-18
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8602

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population without stroke	No Intervention	1. Control population in a case-controlled study of prior stroke ; 2. Control population in a case-controlled study of preexisting coronary heart disease; 3. Population in previous community cross-sectional studies .

Primary Outcome Measures

Name	Time	Method
Incidence of Stroke	5 years	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.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China