Ischemic StrokeNCT06549972
Predictive Role of KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of AIS
An observational study of Ischemic Stroke, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Acute Ischemic Stroke
- How many people
- 273 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
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- Age and gender-matched;
- No organic diseases;
- Written informed consent must be signed
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Predictive Role of Early Blood KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of Acute Ischemic Stroke
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.
Read the detailed description
- 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.
- Conditions
- Ischemic Stroke
- Being tested
- Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Ischemic StrokeOther
first-ever anterior circulation AIS (Acute Ischemic Stroke)
| Study group | Role | What they receive |
|---|---|---|
| ischemic stroke group | The ischemic stroke group will be recruited from inpatients in the Department of Neurology at the Northern Campus of Ruijin hospital. Receives: Other: Acute Ischemic Stroke | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset
Secondary outcomes (3)
the mortality
mortality
Measured: 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.
Measured: 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.
Measured: Record progressive stroke within 7 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start12 Aug 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI LONGXUAN, Ruijin Hospital
- Investigators
- Longxuan Li, Doctor, Principal investigator, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549972
- Sponsor's protocol ID
- 2024092
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Early Blood KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06549972
- Acronym / sponsor ID
- 2024092
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ischemic stroke group | – | Other: Acute Ischemic StrokeThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
- Age and gender-matched;
Key exclusion criteria (8 listed)
- Intracranial hemorrhage;
- Pregnancy;
- Stroke with unknown onset time;
- Malignant tumors;
- Hematologic disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Ischemic Strokefirst-ever anterior circulation AIS (Acute Ischemic Stroke) | Other | ischemic stroke group |
Primary outcome
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.
3 secondary outcomes
the mortality
Time frame: Record mortality at 3 months after stroke onset
the occurrence of hemorrhagic transformation
Time frame: Record hemorrhagic transformation within 7 days after stroke onset
the occurrence of progressive stroke
Time frame: Record progressive stroke within 7 days after stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Longxuan Li, Doctor principal investigator
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Modified Rankin Scale (mRS) score (time frame: Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.