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

Predictive Role of Early Blood KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of Acute Ischemic Stroke

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: Acute Ischemic Stroke

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 Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A total of 182 patients with first-ever anterior circulation AIS (Acute Ischemic Stroke) hospitalized in the Neurology Department at the Northern Campus of our hospital will be selected as the observation group, and 91 healthy individuals undergoing physical examination will be chosen as the control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ischemic stroke group; The ischemic stroke group will be recruited from inpatients in the Department of Neurology at the Northern Campus of Ruijin hospital.	Other: Acute Ischemic Stroke; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Modified Rankin Scale (mRS) score	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.	Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the mortality	mortality	Record mortality at 3 months after stroke onset
the occurrence of hemorrhagic transformation	based on brain CT scans to evaluate hemorrhagic transformation of cerebral infarction.	Record hemorrhagic transformation within 7 days after stroke onset
the occurrence of progressive stroke	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.	Record progressive stroke within 7 days after stroke onset

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Longxuan Li, Doctor, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2024092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No