NCT06545591

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jul 2024Dec 2027

Study Start

First participant enrolled

July 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3.5 years

First QC Date

August 4, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

Thrombectomysoluble TREM-1soluble TREM-2

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    90 days

  • excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1

    30 days

  • early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)

    24 hours

  • Hemorrhagic transformation

    72 hours

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients \> 18 years old.
  • Patients with acute large vessel occlusion within 24 hours of onset who will receive endovascular treatment.

You may not qualify if:

  • Impossibility of getting a blood sample.
  • Impossibility of performing the test (Invalid results).
  • Refusal to provide the informed consent by the patient/relative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xingzhi Wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 9, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations