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

Shanghai Jiao Tong University

Status: Completed

Conditions: Ischemic Stroke

Treatments: Other: Acute Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT06549972

2024092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

273 participants in 2 patient groups

ischemic stroke group

Description:

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

Treatment:

Other: Acute Ischemic Stroke

control group (healthy individuals)

Description:

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