## Protocol Section
### Identification Module
**NCT ID:** NCT06422572

**Brief Title:** Tissue Kallikrein Protect Against Ischemic Stroke

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

#### Organization Study ID Info
**ID:** TJ-IRB202303109
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** National Natural Science Foundation of China

#### Lead Sponsor

**Class:** OTHER

**Name:** Qin Zhang

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Qin Zhang

**Investigator Title:** PROFESSOR

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Stroke, Ischemic

**Keywords:**

- Stroke

### Design Module

#### Bio Spec

**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.

**Retention:** NONE_RETAINED

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 8602

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 .

**Intervention Names:**

- Other: No Intervention

**Label:** Population without stroke

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Population without stroke

**Description:** No Intervention

**Name:** No Intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Incidence of Stroke

**Time Frame:** 5 years

### 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wuhan

**Country:** China

**Facility:** Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

**State:** Hubei

**Zip:** 430030

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital

**Name:** QIN Zhang, phd

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M2400

- Name: Ischemic Stroke

- Relevance: HIGH

- As Found: Stroke, Ischemic

- ID: M10543

- Name: Ischemia

- Relevance: HIGH

- As Found: Ischemic

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

- ID: D000083242

- Term: Ischemic Stroke

- ID: D000007511

- Term: Ischemia

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M10638

- Name: Kallikreins

- Relevance: LOW

- As Found: Unknown

- ID: M5197

- Name: Bradykinin

- Relevance: LOW

- As Found: Unknown

- ID: M10725

- Name: Kininogens

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
