The Temporal Cellular Landscape of the Adaptive Immune System in Patients With Acute Stroke

NCT04852445 | Unknown

• 1 other identifier: TAPAS
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic University Medical Center Amsterdam

Amsterdam, North Holland, 1100 AZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, lymphoid tissue

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

D van de Beek, MD PhD

CONTACT

0205669111; d.vandebeek@amsterdamumc.nl

W F Westendorp, MD PhD

CONTACT

0205669111; w.f.westendorp@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The temporal cellular landscape of the adaptive immune system in patients with acute stroke

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2023
• Study Completion: August 15, 2023
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

NL (1)