Stroke, AcuteTAPASNCT04852445
The Temporal Cellular Landscape of the Adaptive Immune System in Patients With Acute Stroke
An observational study of Stroke, Acute, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Despite novel acute therapies the global burden of stroke remains high worldwide. Targeting the immune response after stroke has the potential to improve recovery in all stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- How many people
- 103 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2021to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: we will include: 60 patients aged 18 years or older with clinical symptoms of hemispheric ischemic stroke due to occlusion of a large cerebral blood vessel, onset within 48 hours and NIHSS of 1 or more; 30 healthy age- and sex- matched controls; 10 patients undergoing carotid endarterectomy within 30 days after stroke and 3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis.
Inclusioncriteria
In order to be eligible to participate in part 1 of this study (serial blood sampling), a subject must meet all of the following criteria:
- age 18 years or older,
- clinical symptoms of hemispheric ischemic stroke due to occlusion of a large vessel
- an onset of symptoms less than 48 h
- a score of 1 or more on the National Institutes of Health Stroke Scale (NIHSS)
- admission to hospital
- written informed consent obtained
For the control arm of part 1 of the study:
- age 18 years or older
- increased risk of cardiovascular disease (defined as a previous cardiovascular event other than stroke or one of the following risk factors: smoking, hypertension, hypercholesterolemia or diabetes mellitus)
- written informed consent obtained
- scheduled blood draw ordered at the Neurology outpatient clinic at Amsterdam UMC (location AMC) for non-vascular non-immunological disease
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic University Medical Center Amsterdam
Amsterdam, North Holland, 1100 AZ
D. van de Beek, Prof. Dr., 0205669111
WF Westendorp, Dr., 0205669111, w.f.westendorp@amsterdamumc.nl
About this study
Despite novel acute therapies the global burden of stroke remains high worldwide. Targeting the immune response after stroke has the potential to improve recovery in all stroke patients. Experimental studies suggest important roles for T-lymphocytes, especially anti-inflammatory regulatory T cells, in the evolution of stroke and neurological deficit. Objectives of this study are to either confirm or refute the hypothesis that a subset of brain regulatory T cells exists in humans and expands after stroke and to identify immunological biomarkers that can be used in stroke clinical trials targeting the adaptive immune system.
Read the detailed description
Rationale: despite novel acute therapies the global burden of stroke remains high worldwide. Targeting the immune response after stroke has the potential to improve recovery in all stroke patients. Experimental studies suggest important roles for T-lymphocytes, especially anti-inflammatory regulatory T cells, in the evolution of stroke and neurological deficit.
Objective:
- To confirm that patients experience an increase and migration of CD4+CD25+FoxP3+ "brain" Tregs..
- To characterize and subgroup brain T reg cells; to assess clonality of the T reg cells in order to determine whether a specific antigen-reaction is present; to assess whether specific antigen-directed FoxP3+ brain Treg cells are recruited through cervical lymph nodes and subsequently migrate towards the brain; to assess whether T reg cells play a role in neurotoxic astrogliosis after stroke.
Study design: case control study.
Study population: we will include: 60 patients aged 18 years or older with clinical symptoms of hemispheric ischemic stroke due to occlusion of a large cerebral blood vessel, onset within 48 hours and NIHSS of 1 or more; 30 healthy age- and sex- matched controls; 10 patients undergoing carotid endarterectomy within 30 days after stroke and 3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis.
Main study parameters/endpoints: we will assess the amount and characteristics of regulatory T cells in peripheral blood and lymph nodes and compare these with patients without stroke.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: in 60 patients blood will be sampled at 9 time points. In addition, neurologic examination at 5 time points, 1 MRI scan and 1 telephone interview will be performed. In 10 patients who undergo carotid endarterectomy, a lymph node will be extracted and blood will be drawn during this surgery. The study is carried out in both capacitated and incapacitated persons because exclusion of non-communicative stroke patients would lead to a selective patient sample.
- Conditions
- Stroke, Acute
- Medical subject headings
- 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 |
|---|---|---|
| Stroke | We will include: 60 patients aged 18 years or older with clinical symptoms of hemispheric ischemic stroke due to occlusion of a large cerebral blood vessel, onset within 48 hours and NIHSS of 1 or more; | |
| Controls | 30 healthy controls, age- and sex- matched with stroke study population | |
| Carotid arterectomy after stroke | 10 patients undergoing carotid endarterectomy within 30 days after stroke | |
| Carotid endarterectomy for asymptomatic stenosis | 3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulatory T cells
we will assess the amount and characteristics of regulatory T cells in peripheral blood and lymph nodes and compare these with patients without stroke.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start15 Apr 2021
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Aug 2023 (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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Diederik van de Beek, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852445
- Sponsor's protocol ID
- TAPAS
- Acronym
- TAPAS
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Temporal Cellular Landscape of the Adaptive Immune System in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT04852445
- Acronym / sponsor ID
- TAPAS / TAPAS
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 21 Apr 2021 (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.
Despite novel acute therapies the global burden of stroke remains high worldwide. Targeting the immune response after stroke has the potential to improve recovery in all stroke patients. Experimental studies suggest important roles for T-lymphocytes, especially anti-inflammatory regulatory T cells, in the evolution of stroke and neurological deficit. Objectives of this study are to either confirm or refute the hypothesis that a subset of brain regulatory T cells exists in humans and expands after stroke and to identify immunological biomarkers that can be used in stroke clinical trials targeting the adaptive immune system.
Detailed description
Rationale: despite novel acute therapies the global burden of stroke remains high worldwide. Targeting the immune response after stroke has the potential to improve recovery in all stroke patients. Experimental studies suggest important roles for T-lymphocytes, especially anti-inflammatory regulatory T cells, in the evolution of stroke and neurological deficit.
Objective:
- To confirm that patients experience an increase and migration of CD4+CD25+FoxP3+ "brain" Tregs..
- To characterize and subgroup brain T reg cells; to assess clonality of the T reg cells in order to determine whether a specific antigen-reaction is present; to assess whether specific antigen-directed FoxP3+ brain Treg cells are recruited through cervical lymph nodes and subsequently migrate towards the brain; to assess whether T reg cells play a role in neurotoxic astrogliosis after stroke.
Study design: case control study.
Study population: we will include: 60 patients aged 18 years or older with clinical symptoms of hemispheric ischemic stroke due to occlusion of a large cerebral blood vessel, onset within 48 hours and NIHSS of 1 or more; 30 healthy age- and sex- matched controls; 10 patients undergoing carotid endarterectomy within 30 days after stroke and 3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis.
Main study parameters/endpoints: we will assess the amount and characteristics of regulatory T cells in peripheral blood and lymph nodes and compare these with patients without stroke.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: in 60 patients blood will be sampled at 9 time points. In addition, neurologic examination at 5 time points, 1 MRI scan and 1 telephone interview will be performed. In 10 patients who undergo carotid endarterectomy, a lymph node will be extracted and blood will be drawn during this surgery. The study is carried out in both capacitated and incapacitated persons because exclusion of non-communicative stroke patients would lead to a selective patient sample.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –We will include: 60 patients aged 18 years or older with clinical symptoms of hemispheric ischemic stroke due to occlusion of a large cerebral blood vessel, onset within 48 hours and NIHSS of 1 or more; |
| Controls | – | –30 healthy controls, age- and sex- matched with stroke study population |
| Carotid arterectomy after stroke | – | –10 patients undergoing carotid endarterectomy within 30 days after stroke |
| Carotid endarterectomy for asymptomatic stenosis | – | –3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- we will include: 60 patients aged 18 years or older with clinical symptoms of hemispheric ischemic stroke due to occlusion of a large cerebral blood vessel, onset within 48 hours and NIHSS of 1 or more; 30 healthy age- and sex- matched controls; 10 patients undergoing carotid endarterectomy within 30 days after stroke and 3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis.
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
Regulatory T cells
Time frame: 28 days
we will assess the amount and characteristics of regulatory T cells in peripheral blood and lymph nodes and compare these with patients without stroke.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact D van de Beek, MD PhD (0205669111, d.vandebeek@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regulatory T cells (time frame: 28 days). 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 21 Apr 2021.