Tissue Kallikrein Protect Against Ischemic Stroke

May 18, 2024 updated by: Qin Zhang

The Role of Tissue Kallikrein - Bradykinin System Targeting the Protection of Neurovascular Units in Ischemic Areas of Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8602

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

  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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Population without stroke
  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 .
Other: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Stroke
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qin Zhang

Collaborators

National Natural Science Foundation of China

Investigators

  • Principal Investigator: QIN Zhang, phd, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 18, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 18, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202303109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke, Ischemic

Clinical Trials on No Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe