Stroke AcuteClotBioInsightNCT07033988
Study of Inflammatory Cells in the Blood and Cerebral Thrombus of Patients Affected by Cerebral Ischemia
An observational study of Stroke Acute, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is an observational, prospective and retrospective, single-center study of thrombotic material and blood samples obtained from patients undergoing mechanical endovascular thrombectomy for ischemic stroke caused by large vessel occlusion or stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- How many people
- 380 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2025to May 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study focuses on adult patients experiencing ischemic stroke presenting at the emergency department/ neurology department of the Hospital of inclusion due to a large vessel occlusion and/or stenosis, undergoing standard diagnostic and therapeutic procedures involving mechanical thrombectomy, thrombolysis or standard medical care.
Who may be able to join
- Age ≥ 18 years.
- Presentation to the emergency department with symptoms and/or signs suggestive of:
- An acute cerebrovascular event
- Stroke mimics
- Stroke-related risk factors (e.g., atrial fibrillation, endocarditis, significant internal carotid stenosis, neoplasms, systemic infections)
- Undergoing one of the following treatments:
Show all 12Show fewer
- Mechanical thrombectomy
- Intravenous thrombolysis
- Standard medical therapy
- Provision of informed consent, either:
- Directly from the conscious patient
- Via appropriate procedures for unconscious patients
Who cannot join
- Pregnancy or breastfeeding
- Presence of a known autoimmune disease that could interfere with the interpretation of biomarker analyses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Neurology
Milan
Neurology Department, 00390226432755, strokeunit@hsr.it
About this study
Official title: Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways
This is an observational, prospective and retrospective, single-center study of thrombotic material and blood samples obtained from patients undergoing mechanical endovascular thrombectomy for ischemic stroke caused by large vessel occlusion or stenosis.
The overarching aim of this study is to advance the understanding of the pathogenesis of cerebral ischemia and to support the development of novel therapeutic strategies for cerebrovascular disease. Specifically, the research seeks to elucidate the pathophysiological mechanisms involved in thrombus formation and stabilization that lead to ischemic events, identify thrombus compositions associated with distinct stroke etiologies, and determine features predictive of resistance to current intravenous thrombolytic therapies. In addition, the study aims to discover novel therapeutic targets and to identify circulating blood biomarkers indicative of an elevated risk of thrombosis.
- Conditions
- Stroke Acute
- Keywords
- stroke, thrombectomy, clot, inflammation, biomarker, pathphysiology
- Medical subject headings
- Stroke, Inflammation
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 |
|---|---|---|
| Stroke_Patients | This cohort includes adult patients diagnosed with acute ischemic stroke due to large vessel occlusion (LVO); subgroups within the cohort may include patients with different etiologies based on standard diagnostic classifications and stratification may be performed by response to thrombolysis, histological thrombus composition, or systemic biomarkers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of leukocyte Infiltration in Thrombus
Leukocyte will be quantified in thrombus sections using immunohistochemistry or immunofluorescence staining for neutrophil markers such as CD45, Cd11b, etc..
Measured: 01.07.2025 up to 06.05.2030
Assess the number of neutrophil extracellular traps (NETS)
NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).
Measured: from 6/2025 to 5/2030
Secondary outcomes (2)
Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.
Histological components of the thrombus-including red blood cells (RBCs), fibrin, von Willebrand factor (vWF), and platelets-will be evaluated using immunohistochemistry and immunofluorescence staining. Quantification will be expressed as percentage area fraction (% of total thrombus area) occupied by each component, as assessed by digital image analysis of stained slides.
Measured: 01.08.2025 - 01-05-2030
Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients
Plasma cytokines will be measured using multiplex immunoassays or ELISA-based methods from peripheral blood samples collected during the acute and subacute phases of ischemic stroke. Concentrations (pg/mL) of cytokines will be quantified and reported as continuous variables to assess systemic inflammatory responses.
Measured: 01.08.2025 - 01.05.2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, University of Manchester, German Cancer Research Center
- Responsible party
- Principal investigator, Bacigaluppi Marco, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033988
- Sponsor's protocol ID
- CET 96-2025
- Acronym
- ClotBioInsight
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 24 Jun 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways
- ClinicalTrials.gov ID
- NCT07033988
- Acronym / sponsor ID
- ClotBioInsight / CET 96-2025
- Conditions
- Stroke Acute
- Keywords
- stroke, thrombectomy, clot, inflammation, biomarker, pathphysiology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- University of Zurich, University of Manchester, German Cancer Research Center
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 24 Jun 2025 (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 is an observational, prospective and retrospective, single-center study of thrombotic material and blood samples obtained from patients undergoing mechanical endovascular thrombectomy for ischemic stroke caused by large vessel occlusion or stenosis.
The overarching aim of this study is to advance the understanding of the pathogenesis of cerebral ischemia and to support the development of novel therapeutic strategies for cerebrovascular disease. Specifically, the research seeks to elucidate the pathophysiological mechanisms involved in thrombus formation and stabilization that lead to ischemic events, identify thrombus compositions associated with distinct stroke etiologies, and determine features predictive of resistance to current intravenous thrombolytic therapies. In addition, the study aims to discover novel therapeutic targets and to identify circulating blood biomarkers indicative of an elevated risk of thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke_Patients | – | –This cohort includes adult patients diagnosed with acute ischemic stroke due to large vessel occlusion (LVO); subgroups within the cohort may include patients with different etiologies based on standard diagnostic classifications and stratification may be performed by response to thrombolysis, histological thrombus composition, or systemic biomarkers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study focuses on adult patients experiencing ischemic stroke presenting at the emergency department/ neurology department of the Hospital of inclusion due to a large vessel occlusion and/or stenosis, undergoing standard diagnostic and therapeutic procedures involving mechanical thrombectomy, thrombolysis or standard medical care.
Key inclusion criteria (12 listed)
- Age ≥ 18 years.
- Presentation to the emergency department with symptoms and/or signs suggestive of:
- An acute cerebrovascular event
- Stroke mimics
- Stroke-related risk factors (e.g., atrial fibrillation, endocarditis, significant internal carotid stenosis, neoplasms, systemic infections)
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding
- Presence of a known autoimmune disease that could interfere with the interpretation of biomarker analyses
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
Quantification of leukocyte Infiltration in Thrombus
Time frame: 01.07.2025 up to 06.05.2030
Leukocyte will be quantified in thrombus sections using immunohistochemistry or immunofluorescence staining for neutrophil markers such as CD45, Cd11b, etc..
Assess the number of neutrophil extracellular traps (NETS)
Time frame: from 6/2025 to 5/2030
NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).
2 secondary outcomes
Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.
Time frame: 01.08.2025 - 01-05-2030
Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients
Time frame: 01.08.2025 - 01.05.2030
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 24 Jun 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.
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 Stroke Acute, run by IRCCS San Raffaele at 1 site in Italy.
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 12 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Jun 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 Italy. 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 Principal Investigator (00390226439816, ctc.trialstartup@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of leukocyte Infiltration in Thrombus (time frame: 01.07.2025 up to 06.05.2030). The study lists 2 primary outcomes in all. 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 24 Jun 2025.