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

• Conditions: Ischemic Stroke
• Interventions: Other: Acute Ischemic Stroke

• Registration Number: NCT06549972
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-08
• Study Start: 2024-08-12
• Study First Posted: 2024-08-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 273

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ischemic stroke group	Acute Ischemic Stroke	The ischemic stroke group will be recruited from inpatients in the Department of Neurology at the Northern Campus of Ruijin hospital.

Primary Outcome Measures

Name	Time	Method
the Modified Rankin Scale (mRS) score	Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset	0 No symptoms.1 No significant disability; able to carry out all usual activities, despite some symptoms. 2 Slight disability; able to look after own affairs without assistance, but unable to carry out all previous activities. 3 Moderate disability; requires some help, but able to walk unassisted.4 Moderately severe disability; unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 Severe disability; requires constant nursing care and attention, bedridden, incontinent. 6 Dead.

Secondary Outcome Measures

Name	Time	Method
the occurrence of hemorrhagic transformation	Record hemorrhagic transformation within 7 days after stroke onset	based on brain CT scans to evaluate hemorrhagic transformation of cerebral infarction.
the occurrence of progressive stroke	Record progressive stroke within 7 days after stroke onset	Neurological deficits are assessed using the NIHSS score. Progressive stroke is diagnosed if the NIHSS score increases by 2 points within 7 days after stroke onset.
the mortality	Record mortality at 3 months after stroke onset	mortality

Trial Locations

Locations (1)

Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China