Clinical trial NCT06549972: Predictive Role of KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of AIS
Official title: Predictive Role of Early Blood KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ischemic Stroke
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 273
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the Modified Rankin Scale (mRS) score
timeFrame: Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset
Secondary outcomes:
measure: the mortality
timeFrame: Record mortality at 3 months after stroke onset
measure: the occurrence of hemorrhagic transformation
timeFrame: Record hemorrhagic transformation within 7 days after stroke onset
measure: the occurrence of progressive stroke
timeFrame: Record progressive stroke within 7 days after stroke onset
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School
name: Longxuan Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: