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

NCT06549972 | Completed

• 1 other identifier: 2024092
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the mortality

  Record mortality at 3 months after stroke onset

• the occurrence of hemorrhagic transformation

  Record hemorrhagic transformation within 7 days after stroke onset

• the occurrence of progressive stroke

  Record progressive stroke within 7 days after stroke onset

Study Arms (2)

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

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.

Interventions

Acute Ischemic Stroke OTHER

first-ever anterior circulation AIS (Acute Ischemic Stroke)

ischemic stroke group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

For AIS patients, 10 ml of elbow venous blood will be collected at admission and then at 24 hours and 7 days after stroke onset. For healthy individuals, 10 ml of fasting elbow venous blood will be collected once. The dynamic changes and differential expression characteristics of a group of neuroinflammatory molecules, including KLK10, sTREM2, and GFAP in plasma will be observed.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Longxuan Li, Doctor

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 12, 2024
• Study Start: August 12, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)