NCT Number: NCT07754942
The goal of this observational study is to describe the local change in interleukin-6 (IL-6) across a blood clot in adults with acute ischemic stroke caused by anterior circulation large vessel occlusion who are undergoing mechanical thrombectomy.
The main questions it aims to answer are:
* Is the level of IL-6 different in arterial blood collected beyond the clot compared with arterial blood collected before the clot during mechanical thrombectomy? * Is the trans-thrombus IL-6 difference associated with functional independence 90 days after stroke and with complications related to reperfusion injury? There is no comparison group and no experimental treatment. Researchers will compare paired blood samples collected from opposite sides of the clot in the same participant. Blood collected from a peripheral vein at hospital admission will be used only as a supportive reference for systemic inflammation.
Participants will:
* Receive standard mechanical thrombectomy and stroke care determined by their treating clinical team. * Have small blood samples collected at planned time points, including paired arterial blood samples collected during the thrombectomy procedure. * Have clinical and imaging information collected from their medical records and have functional status assessed 90 days after stroke.
The study will not delay or change standard stroke treatment.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Xiamen, Fujian, 361004, China
Jingcong Zhuang, PhD
SUB_INVESTIGATOR
Leihua Weng, PhD
SUB_INVESTIGATOR
Liangyi Chen, MD
SUB_INVESTIGATOR
Qingwei Yang, PhD
SUB_INVESTIGATOR
Xingyu Chen, MD
CONTACT
Yibin Xiao, MD
CONTACT
Yibin Xiao, MD
SUB_INVESTIGATOR
Zhongjie Chen, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adults with acute ischemic stroke due to anterior circulation large vessel occlusion who undergo clinically indicated mechanical thrombectomy. All participants receive standard stroke care determined by the treating clinical team; no experimental intervention is assigned. Paired arterial blood samples are collected during thrombectomy from sites proximal and distal to the thrombus. A peripheral venous blood sample collected at hospital admission is used as a supportive systemic reference. Clinical, imaging, procedural, and 90-day functional outcome data are collected prospectively.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus interleukin-6 (IL-6) gradient, defined as ln [T2b/T2a], where T2b is the IL-6 concentration in arterial plasma collected distal to the thrombus and T2a is the IL-6 concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus Interleukin-1β gradient, defined as ln[T2b/T2a], where T2b is the Interleukin-1β concentration in arterial plasma collected distal to the thrombus and T2a is the Interleukin-1β concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus Interleukin-17 gradient, defined as ln[T2b/T2a], where T2b is the Interleukin-17 concentration in arterial plasma collected distal to the thrombus and T2a is the Interleukin-17 concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus Complement C3 gradient, defined as ln[T2b/T2a], where T2b is the Complement C3 concentration in arterial plasma collected distal to the thrombus and T2a is the Complement C3 concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus Complement C5a gradient, defined as ln[T2b/T2a], where T2b is the Complement C5a concentration in arterial plasma collected distal to the thrombus and T2a is the Complement C5a concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus Malondialdehyde gradient, defined as ln[T2b/T2a], where T2b is the Malondialdehyde concentration in arterial plasma collected distal to the thrombus and T2a is the Malondialdehyde concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus Matrix Metalloproteinase-9 gradient, defined as ln[T2b/T2a], where T2b is the Matrix Metalloproteinase-9 concentration in arterial plasma collected distal to the thrombus and T2a is the Matrix Metalloproteinase-9 concentration in arterial plasma collected proximal to the thrombus.
Time frame: 90 (±14) days
The ordinal distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death).
Time frame: 90 (±14) days
The proportion of mRS score of 0-2 at 90 days.
Time frame: 90 (±14) days
The proportion of mRS score of 0-3 at 90 days.
Time frame: 24 (±12) hours
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Time frame: 7 (±1) days or at discharge
The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)
Time frame: 90 (±14) days
EQ-5D-5L scale score at 90 days.
Time frame: 24 (±12) hours
Incidence of symptomatic intracranial hemorrhage within 36 hours from randomization (Heidelberg criteria)
Time frame: 24 (±12) hours
Incidence of any intracranial hemorrhage within 36 hours from randomization (Heidelberg classification)
Time frame: 24 (±12) hours
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from randomization
Time frame: 7 (±1) days or at discharge
Cerebral edema causing substantial mass effect, defined by neurological deterioration with imaging evidence of space-occupying cerebral swelling and/or the requirement for decompressive hemicraniectomy
Time frame: 90 days
All cause death within 90 days.
Time frame: 1 year
The ordinal distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death).
Contact information is provided by the study sponsor or research team.
Zhongshan Hospital Xiamen University
Other
Local-to-Systemic Inflammatory Biomarker Gradients and 90-Day Functional Outcomes in Patients With Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion Undergoing Mechanical Thrombectomy: A Prospective Observational Cohort Study
Acronym: IMPACT-LVO
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