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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06549972
Enrollment
273
Registered
2024-08-12
Start date
2024-08-12
Completion date
2025-06-30
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

OTHERAcute Ischemic Stroke

first-ever anterior circulation AIS (Acute Ischemic Stroke)

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
the Modified Rankin Scale (mRS) scoreRecord the Modified Rankin Scale (mRS) score at 3 months after stroke onset0 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

MeasureTime frameDescription
the mortalityRecord mortality at 3 months after stroke onsetmortality
the occurrence of hemorrhagic transformationRecord hemorrhagic transformation within 7 days after stroke onsetbased on brain CT scans to evaluate hemorrhagic transformation of cerebral infarction.
the occurrence of progressive strokeRecord progressive stroke within 7 days after stroke onsetNeurological 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026