Acute Ischemic StrokeNCT06545591
Predictive Role of sTREM in Endovascular Thrombectomy Outcomes
An observational study of Acute Ischemic Stroke, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
Soluble triggering receptor expressed on myeloid cells (sTREM), which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: There will be 200 patients with stroke who underwent EVT (Endovascular Therapy), 50 patients with non--EVT stroke and 50 non--stroke controls.
Who may be able to join
- Patients > 18 years old.
- Patients with acute large vessel occlusion within 24 hours of onset who will receive endovascular treatment.
Who cannot join
- Impossibility of getting a blood sample.
- Impossibility of performing the test (Invalid results).
- Refusal to provide the informed consent by the patient/relative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology
Xuzhou, Jiangsu
Xingzhi Wang, MD, 0086-13852000759, wxz1220@126.com
About this study
Official title: Soluble Soluble Triggering Receptors Expressed on Myeloid Cells (sTREM) Predict Outcomes in Stroke Patients Receiving Endovascular Thrombectomy
Soluble triggering receptor expressed on myeloid cells (sTREM), which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. This study is to investigatethe prognostic roles of sTREM (sTREM1 and sTREM2) in patients with ischemic stroke who underwent endovascular thrombectomy (EVT).
Read the detailed description
For acute ischemic stroke, the current treatment strategy involves timely recanalization by intravenous thrombolysis and endovascular thrombectomy (EVT). Patients receiving EVT are more likely to achieve successful revascularization and long--term functional independence compared with those receiving standard medical treatment.1 In patients receiving EVT, significant predictors of a favorable functional outcome include minor initial stroke severity, successful recanalization, and shorter onset--to--treatment time. However, unfavorable outcomes can occur even after early successful recanalization in some cases.Triggering receptors expressed on myeloid cells (TREM-1 and TREM-2) are a familyof receptors involved in the immune system expressed on a variety of innate cells of the myeloid lineage, including microglia. sTREM, which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. We enrolled adult patients with stroke who received EVT, with blood sampling immediately before (T1) and after EVT (T2), and at 24 hours after EVT (T3). Non--stroke controls and patients with non--EVT stroke were also enrolled. The plasma concentration of sTREM1 and sTREM2 were analyzed by ELISA. The medical information, image findings and levels of plasma sTREM1 and sTREM2 were analyzed to clarify the association with poor functional outcome (modified Rankin Scale 4-6) at 3 months after stroke.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Thrombectomy, soluble TREM-1, soluble TREM-2
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EVT-stroke group | Patients with ischemic stroke who received endovascular thrombectomy (EVT) treatment | |
| non--EVT stroke group | The non--EVT stroke group was composed of patients with ischemic stroke without endovascular thrombectomy (EVT) treatment during the same period | |
| non--stroke control group | The non--stroke control group was composed of randomly selected stroke--free, age--matched and sex--matched individuals recruited from the health examination center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes in plasma levels of sTREM-1 and sTREM-2 following Endovascular Therapy
Plasma levels of sTREM-1 and sTREM-2 will be quantified using the ELISA method.
Measured: From baseline to immediately, 24 hours, 3 days, and 7 days after Endovascular Therapy
Secondary outcomes (4)
favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2
mRS ranges from 0-6, high score means poor outcome
Measured: 90 days
excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1
mRS ranges from 0-6, high score means poor outcome
Measured: 30 days
early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)
NIHSS ranges from 0-22, with high score meaning severe neurological deficit.
Measured: 24 hours
Hemorrhagic transformation
Hemorrhagic transformation was diagnosed by Computed tomographic scans usually performed 24 to 72 hours after the procedure.Symptomatic intracranial hemorrhage was defined as neurologic deterioration (an increase of 4 or more points in the score on the NIHSS) and evidence of intracranial hemorrhage on imaging studies.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545591
- Sponsor's protocol ID
- XYFY2024-KL335-01
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Soluble Triggering Receptors Expressed on Myeloid Cells (sTREM) Predict Outcomes in Stroke Patients Receiving Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT06545591
- Acronym / sponsor ID
- XYFY2024-KL335-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Thrombectomy, soluble TREM-1, soluble TREM-2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 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.
Soluble triggering receptor expressed on myeloid cells (sTREM), which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. This study is to investigatethe prognostic roles of sTREM (sTREM1 and sTREM2) in patients with ischemic stroke who underwent endovascular thrombectomy (EVT).
Detailed description
For acute ischemic stroke, the current treatment strategy involves timely recanalization by intravenous thrombolysis and endovascular thrombectomy (EVT). Patients receiving EVT are more likely to achieve successful revascularization and long--term functional independence compared with those receiving standard medical treatment.1 In patients receiving EVT, significant predictors of a favorable functional outcome include minor initial stroke severity, successful recanalization, and shorter onset--to--treatment time. However, unfavorable outcomes can occur even after early successful recanalization in some cases.Triggering receptors expressed on myeloid cells (TREM-1 and TREM-2) are a familyof receptors involved in the immune system expressed on a variety of innate cells of the myeloid lineage, including microglia. sTREM, which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. We enrolled adult patients with stroke who received EVT, with blood sampling immediately before (T1) and after EVT (T2), and at 24 hours after EVT (T3). Non--stroke controls and patients with non--EVT stroke were also enrolled. The plasma concentration of sTREM1 and sTREM2 were analyzed by ELISA. The medical information, image findings and levels of plasma sTREM1 and sTREM2 were analyzed to clarify the association with poor functional outcome (modified Rankin Scale 4-6) at 3 months after stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVT-stroke group | – | –Patients with ischemic stroke who received endovascular thrombectomy (EVT) treatment |
| non--EVT stroke group | – | –The non--EVT stroke group was composed of patients with ischemic stroke without endovascular thrombectomy (EVT) treatment during the same period |
| non--stroke control group | – | –The non--stroke control group was composed of randomly selected stroke--free, age--matched and sex--matched individuals recruited from the health examination center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- There will be 200 patients with stroke who underwent EVT (Endovascular Therapy), 50 patients with non--EVT stroke and 50 non--stroke controls.
Key inclusion criteria (2 listed)
- Patients > 18 years old.
- Patients with acute large vessel occlusion within 24 hours of onset who will receive endovascular treatment.
Key exclusion criteria (3 listed)
- Impossibility of getting a blood sample.
- Impossibility of performing the test (Invalid results).
- Refusal to provide the informed consent by the patient/relative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic changes in plasma levels of sTREM-1 and sTREM-2 following Endovascular Therapy
Time frame: From baseline to immediately, 24 hours, 3 days, and 7 days after Endovascular Therapy
Plasma levels of sTREM-1 and sTREM-2 will be quantified using the ELISA method.
4 secondary outcomes
favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2
Time frame: 90 days
excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1
Time frame: 30 days
early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours
Hemorrhagic transformation
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
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 Acute Ischemic Stroke, run by The Affiliated Hospital of Xuzhou Medical University 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingzhi Wang, MD (0086-13852000759, wxz1220@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes in plasma levels of sTREM-1 and sTREM-2 following Endovascular Therapy (time frame: From baseline to immediately, 24 hours, 3 days, and 7 days after Endovascular Therapy). 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 9 Aug 2024.