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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ischemic stroke group | The ischemic stroke group will be recruited from inpatients in the Department of Neurology at the Northern Campus of Ruijin hospital. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Ischemic Stroke | Other | first-ever anterior circulation AIS (Acute Ischemic Stroke) |
|
| 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 |
| 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. |
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Inclusion Criteria:
for AIS patients:
for healthy controls:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Longxuan Li, Doctor | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2024 | Aug 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2024 | Aug 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
| 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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |