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Completed

NCT Number: NCT06549972

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

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200025, China

About this study

  • Informed Consent and Recruitment: Participants will be recruited based on inclusion and exclusion criteria.
  • divided two groups: the case group(ischemic stroke group) and the control group(healthy individuals).
  • 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.
  • Second survey(24 hours after onset): NIHSS Score and Plasma Levels of KLK10, sTREM2, and GFAP Detection.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acute Ischemic Stroke

Other

first-ever anterior circulation AIS (Acute Ischemic Stroke)

Primary outcomes

  1. the Modified Rankin Scale (mRS) score

    Time frame: Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset

    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.

Secondary outcomes

  1. the mortality

    Time frame: Record mortality at 3 months after stroke onset

    mortality

  2. the occurrence of hemorrhagic transformation

    Time frame: Record hemorrhagic transformation within 7 days after stroke onset

    based on brain CT scans to evaluate hemorrhagic transformation of cerebral infarction.

  3. the occurrence of progressive stroke

    Time frame: Record progressive stroke within 7 days after stroke onset

    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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Predictive Role of Early Blood KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of Acute Ischemic Stroke

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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