Acute Ischemic StrokeIMPACT-LVONCT07754942
Inflammatory Markers and Prognosis After Cerebral Thrombectomy in Large Vessel Occlusion
An observational study of Acute Ischemic Stroke and Large Vessel Occlusion, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion
- What is being tested?
- Prospective Mechanical Thrombectomy Cohort
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 2029
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: This single-center prospective observational cohort will enroll consecutive adults with acute ischemic stroke due to anterior circulation large vessel occlusion who undergo clinically indicated mechanical thrombectomy. Participants receive standard stroke care determined by the treating clinical team; no experimental treatment is assigned. During thrombectomy, paired arterial plasma samples are collected from locations proximal and distal to the thrombus when technically feasible and without delaying or altering routine treatment. An admission peripheral venous blood sample is collected as a supportive reference for systemic inflammation. Clinical, imaging, procedural, laboratory, and 90-day follow-up data are collected prospectively.
Who may be able to join
- Age 18 years or older.
- Acute ischemic stroke caused by anterior circulation large vessel occlusion, confirmed by routine vascular imaging or digital subtraction angiography.
- Undergoing clinically indicated mechanical thrombectomy according to routine clinical practice.
- Provision of written informed consent by the participant or legally authorized representative, in accordance with local ethics requirements.
Who cannot join
- Posterior circulation large vessel occlusion.
- Mechanical thrombectomy not performed.
- Known active systemic infection, active malignancy, or chronic inflammatory/autoimmune disease requiring systemic immunosuppressive treatment, when these conditions are expected to substantially affect inflammatory biomarker measurements.
- Pregnancy or breastfeeding, if required by the local ethics committee.
- Enrollment in another interventional study that could affect inflammatory biomarker measurements or clinical outcome assessment.
- Inability to obtain informed consent, where consent from a legally authorized representative is not permitted or cannot be obtained.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yibin Xiao, MD contact
China1 site
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
Xingyu Chen, MD, 0592-2590143, 2005chenxingyu@163.com
Yibin Xiao, MD, xiaoyb6@xmu.edu.cn
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Being tested
- Prospective Mechanical Thrombectomy Cohort
- Keywords
- Mechanical Thrombectomy, Anterior Circulation Large Vessel Occlusion, Trans-Thrombus Gradient, Inflammatory Biomarkers, Reperfusion Injury, Modified Rankin Scale, Interleukin-6
- Medical subject headings
- Ischemic Stroke, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Mechanical Thrombectomy CohortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Mechanical Thrombectomy Cohort | 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. Receives: Other: Prospective Mechanical Thrombectomy Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans-Thrombus Interleukin-6 Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Secondary outcomes (12)
Trans-Thrombus Interleukin-1 Beta Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Trans-Thrombus Interleukin-17 Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Trans-Thrombus Complement C3 Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Trans-Thrombus Complement C5a Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Trans-Thrombus Malondialdehyde Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Trans-Thrombus Matrix Metalloproteinase-9 Gradient
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.
Measured: During mechanical thrombectomy, before recanalization
Modified Rankin Score
The ordinal distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death).
Measured: 90 (±14) days
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Measured: 90 (±14) days
Good Function
The proportion of mRS score of 0-3 at 90 days.
Measured: 90 (±14) days
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Measured: 24 (±12) hours
Change in stroke severity
The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)
Measured: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
EQ-5D-5L scale score at 90 days.
Measured: 90 (±14) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingyu Chen, Zhongshan Hospital Xiamen University
- Investigators
- Xingyu Chen, MD, Principal investigator, Zhongshan Hospital Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754942
- Sponsor's protocol ID
- MR-35-24-042541
- Acronym
- IMPACT-LVO
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data, including clinical and biospecimen data, will not be publicly shared because of ethical, privacy, informed-consent, and institutional restrictions. Requests for access to de-identified data for scientifically valid purposes may be considered by the principal investigator and the institution, subject to applicable ethics approval and a data-use agreement. Contact: Xingyu Chen, 2005chenxingyu@163.com
Publications
Shaw BC, Maglinger GB, Ujas T, Rupareliya C, Fraser JF, Grupke S, Kesler M, Gelderblom M, Pennypacker KR, Turchan-Cholewo J, Stowe AM. Isolation and identification of leukocyte populations in intracranial blood collected during mechanical thrombectomy. J Cereb Blood Flow Metab. 2022 Feb;42(2):280-291. doi: 10.1177/0271678X211028496. Epub 2021 Jul 11.
PubMed 34250820Martha SR, Cheng Q, Fraser JF, Gong L, Collier LA, Davis SM, Lukins D, Alhajeri A, Grupke S, Pennypacker KR. Expression of Cytokines and Chemokines as Predictors of Stroke Outcomes in Acute Ischemic Stroke. Front Neurol. 2020 Jan 15;10:1391. doi: 10.3389/fneur.2019.01391. eCollection 2019.
PubMed 32010048Fraser JF, Collier LA, Gorman AA, Martha SR, Salmeron KE, Trout AL, Edwards DN, Davis SM, Lukins DE, Alhajeri A, Grupke S, Roberts JM, Bix GJ, Pennypacker KR. The Blood And Clot Thrombectomy Registry And Collaboration (BACTRAC) protocol: novel method for evaluating human stroke. J Neurointerv Surg. 2019 Mar;11(3):265-270. doi: 10.1136/neurintsurg-2018-014118. Epub 2018 Jul 31.
PubMed 30064997Turner RJ, Sharp FR. Implications of MMP9 for Blood Brain Barrier Disruption and Hemorrhagic Transformation Following Ischemic Stroke. Front Cell Neurosci. 2016 Mar 4;10:56. doi: 10.3389/fncel.2016.00056. eCollection 2016.
PubMed 26973468Ma Y, Liu Y, Zhang Z, Yang GY. Significance of Complement System in Ischemic Stroke: A Comprehensive Review. Aging Dis. 2019 Apr 1;10(2):429-462. doi: 10.14336/AD.2019.0119. eCollection 2019 Apr.
PubMed 31011487Lambertsen KL, Finsen B, Clausen BH. Post-stroke inflammation-target or tool for therapy? Acta Neuropathol. 2019 May;137(5):693-714. doi: 10.1007/s00401-018-1930-z. Epub 2018 Nov 27.
PubMed 30483945Jayaraj RL, Azimullah S, Beiram R, Jalal FY, Rosenberg GA. Neuroinflammation: friend and foe for ischemic stroke. J Neuroinflammation. 2019 Jul 10;16(1):142. doi: 10.1186/s12974-019-1516-2.
PubMed 31291966Anrather J, Iadecola C. Inflammation and Stroke: An Overview. Neurotherapeutics. 2016 Oct;13(4):661-670. doi: 10.1007/s13311-016-0483-x.
PubMed 27730544Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.
PubMed 21738161Weng JC, Wang J, Li H, Jiao YM, Fu WL, Huo R, Yan ZH, Xu HY, Zhan J, Wang S, Du X, Cao Y, Zhao JZ; Small Unruptured Aneurysms Study Group. Aspirin and Growth of Small Unruptured Intracranial Aneurysm: Results of a Prospective Cohort Study. Stroke. 2020 Oct;51(10):3045-3054. doi: 10.1161/STROKEAHA.120.029967. Epub 2020 Sep 3.
PubMed 32878566Hussein HM, Georgiadis AL, Vazquez G, Miley JT, Memon MZ, Mohammad YM, Christoforidis GA, Tariq N, Qureshi AI. Occurrence and predictors of futile recanalization following endovascular treatment among patients with acute ischemic stroke: a multicenter study. AJNR Am J Neuroradiol. 2010 Mar;31(3):454-8. doi: 10.3174/ajnr.A2006. Epub 2010 Jan 14.
PubMed 20075087Liebeskind DS, Bracard S, Guillemin F, Jahan R, Jovin TG, Majoie CB, Mitchell PJ, van der Lugt A, Menon BK, San Roman L, Campbell BC, Muir KW, Hill MD, Dippel DW, Saver JL, Demchuk AM, Davalos A, White P, Brown S, Goyal M; HERMES Collaborators. eTICI reperfusion: defining success in endovascular stroke therapy. J Neurointerv Surg. 2019 May;11(5):433-438. doi: 10.1136/neurintsurg-2018-014127. Epub 2018 Sep 7.
PubMed 30194109Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available.
PubMed 23920012Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
PubMed 26898852Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.
PubMed 25882510