The Temporal Cellular Landscape of the Adaptive Immune System in Patients With Acute Stroke (TAPAS)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: D van de Beek, MD PhD
- Telefonnummer: 0205669111
- E-mail: d.vandebeek@amsterdamumc.nl
Undersøgelse Kontakt Backup
- Navn: W F Westendorp, MD PhD
- Telefonnummer: 0205669111
- E-mail: w.f.westendorp@amsterdamumc.nl
Studiesteder
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Noord-Holland
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Amsterdam, Noord-Holland, Holland, 1100 AZ
- Rekruttering
- Academic University Medical Center Amsterdam
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Kontakt:
- D. van de Beek, Prof. Dr.
- Telefonnummer: 0205669111
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Kontakt:
- WF Westendorp, Dr.
- Telefonnummer: 0205669111
- E-mail: w.f.westendorp@amsterdamumc.nl
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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;
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Controls
30 healthy controls, age- and sex- matched with stroke study population
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Carotid arterectomy after stroke
10 patients undergoing carotid endarterectomy within 30 days after stroke
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Carotid endarterectomy for asymptomatic stenosis
3 patients without stroke undergoing carotid endarterectomy for asymptomatic carotid stenosis.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Regulatory T cells
Tidsramme: 28 days
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we will assess the amount and characteristics of regulatory T cells in peripheral blood and lymph nodes and compare these with patients without stroke.
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28 days
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TAPAS
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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