Tissue Kallikrein Protect Against Ischemic Stroke | NCT06422572

Studies
Tissue Kallikrein Protect Against Ischemic Stroke

NCT06422572

Sponsor

Qin Zhang

Status

Completed

Last Update Posted

May 21, 2024Actual

Enrollment

8,602Actual

Phase

Not provided

Conditions

Stroke, Ischemic

Interventions

No Intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Dec 30, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

May 7, 2024

First Submission Date that Met QC Criteria

May 18, 2024

First Posted Date

May 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2024

Last Update Posted Date

May 21, 2024Actual

Name	Class
National Natural Science Foundation of China	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

8,602Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Population without stroke		Control population in a case-controlled study of prior stroke ; Control population in a case-controlled study of preexisting coronary heart disease; Population in previous community cross-sectional studies .	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	No Intervention	Population without stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Control population in the previous stroke case-control study;
The CHD case-control population in the previous study;
The population in the community cross-sectional study of the previous study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
QIN Zhang, phd	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Part of the sample consisted of 1210 stroke controls and 905 coronary heart disease controls enrolled from December 2000 to November 2001 in the previous study. The other part comes from 6,487 cases of community population in Rizhao area from May to August 2010.