Predictive Role of KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of AIS

NCT ID: NCT06549972

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2025-06-30

Brief Summary

This study aims to investigate the dynamic changes and differential expression characteristics of neuroinflammatory molecules such as kallikrein-related peptidase 10 (KLK10), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), and glial fibrillary acidic protein (GFAP) in the plasma of patients with first-ever anterior circulation acute ischemic stroke (AIS). It will analyze the correlation between these molecules and the severity of neurological deficits, infarct volume, brain edema, hemorrhagic transformation, progressive stroke, and clinical outcomes at three months. The goal is to assess the predictive value of these molecules for AIS prognosis, guiding early treatment and new molecular targets for prevention and treatment.

Detailed Description

1. Informed Consent and Recruitment: Participants will be recruited based on inclusion and exclusion criteria.

2. divided two groups: the case group(ischemic stroke group) and the control group(healthy individuals).

3. First survey(At the time of admission): baseline Assessment- Survey on gender, age, medical history, smoking, drinking habits, and current medication; NIHSS score at admission; measurement of plasma levels of KLK10, sTREM2, and GFAP; a collection of blood glucose, creatinine, high-sensitivity C-reactive protein, blood cell analysis report, and brain MRI or CT imaging reports.

4. Second survey(24 hours after onset): NIHSS Score and Plasma Levels of KLK10, sTREM2, and GFAP Detection.

5. Third survey(Within 7 days of onset): Obtain brain CT or MRI reports to extract information on infarct volume, brain edema, and hemorrhagic transformation; perform NIHSS scoring to assess the occurrence of progressive stroke.

6. Forth survey( 3 months after onset): Final Assessment<if Good Functional Outcome or Mortality>:Record the Modified Rankin Scale (mRS) score at 3 months after stroke.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

ischemic stroke group

The ischemic stroke group will be recruited from inpatients in the Department of Neurology at the Northern Campus of Ruijin hospital.

Acute Ischemic Stroke

Intervention Type: OTHER

first-ever anterior circulation AIS (Acute Ischemic Stroke)

control group (healthy individuals)

The control group will be recruited from outpatient health check-up populations undergoing routine blood tests, biochemical tests, cranial CT, or MRI.

No interventions assigned to this group

Interventions

Acute Ischemic Stroke

first-ever anterior circulation AIS (Acute Ischemic Stroke)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

for AIS patients:

• Selection of 182 patients with first-ever acute ischemic stroke (AIS) who are hospitalized at our hospital, aged ≥18 years, with no restriction on gender;
• Patients must be admitted within 24 hours of the onset of AIS;
• Diagnosis must be confirmed by cranial magnetic resonance imaging (MRI) or computed tomography (CT);
• All enrolled patients must provide written informed consent.

for healthy controls:

• Age and gender-matched;
• No organic diseases;
• Written informed consent must be signed

Exclusion Criteria

• Intracranial hemorrhage;
• Pregnancy;
• Stroke with unknown onset time;
• Malignant tumors;
• Hematologic disorders;
• Severe liver or kidney dysfunction;
• Recent myocardial infarction (less than 3 months);
• Ongoing anti-inflammatory drug treatment.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

LI LONGXUAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Longxuan Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School

Locations

Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2024092

Identifier Type: -

Identifier Source: org_study_id