Evidence map›Paper›PMID 38413153›Full record

ArticleBMJ open2024

Immune regulation and blood-brain barrier permeability in cerebral small vessel disease: study protocol of the INflammation and Small Vessel Disease (INSVD) study - a multicentre prospective cohort study.

Audrey Low, Sanne van Winden, Lupei Cai, Roy P C Kessels, Marnix C Maas, Robin G Morris, Meritxell Nus, Daniel J Tozer, Anil Tuladhar, Anja van der Kolk and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05746221 (INflammation and Small Vessel Disease Study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05746221 unknown statusnot on this map

INflammation and Small Vessel Disease Study

TypeobservationalSponsorUniversity of CambridgeRan2022 to 2026Enrolled200ConditionsCerebral Small Vessel Diseases, Inflammation, Stroke
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 2 countries.

Audrey LowDepartment of Clinical Neurosciences, University of Cambridge, Cambridge, UK al927@medschl.cam.ac.uk.ORCID 0000-0002-2520-454X
Sanne van WindenDepartment of Neurology, Radboudumc, Nijmegen, The Netherlands.ORCID 0009-0002-3275-968X
Lupei CaiDepartment of Clinical Neurosciences, University of Cambridge, Cambridge, UK.
Roy P C KesselsRadboud University Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.ORCID 0000-0001-9500-9793
Marnix C MaasDepartment of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.ORCID 0000-0002-1781-521X
Robin G MorrisInstitute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.ORCID 0000-0001-7767-5258
Meritxell NusDivision of Cardiovascular Medicine, Department of Medicine, University of Cambridge, Cambridge, UK.ORCID 0000-0002-6378-8910
Daniel J TozerDepartment of Clinical Neurosciences, University of Cambridge, Cambridge, UK.
Anil TuladharDepartment of Neurology, Radboudumc, Nijmegen, The Netherlands.ORCID 0000-0002-4815-2834
Anja van der KolkDepartment of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.ORCID 0000-0002-8267-8848
Rowan WoltersDepartment of Neurology, Radboudumc, Nijmegen, The Netherlands.
Ziad MallatThe Victor Phillip Dahdaleh Heart and Lung Research Institute, Section of Cardiorespiratory Medicine, Department of Medicine, University of Cambridge Medicine, Cambridge, UK.ORCID 0000-0003-0443-7878
Niels P RiksenDepartment of Internal Medicine, Radboudumc, Nijmegen, The Netherlands.ORCID 0000-0001-9197-8124
Hugh MarkusDepartment of Clinical Neurosciences, University of Cambridge, Cambridge, UK.ORCID 0000-0002-9794-5996
Frank-Erik de LeeuwDepartment of Neurology, Radboudumc, Nijmegen, The Netherlands.ORCID 0000-0003-2221-3026
Radboud University Nijmegen · NLUniversity of Cambridge · GBKing's College London · GB

Funding

British Heart Foundation FS/20/23/34784
6 · The paper itself

Abstract

introductionThe INflammation and Small Vessel Disease (INSVD) study aims to investigate whether peripheral inflammation, immune (dys)regulation and blood-brain barrier (BBB) permeability relate to disease progression in cerebral small vessel disease (SVD). This research aims to pinpoint specific components of the immune response in SVD relating to disease progression. This could identify biomarkers of SVD progression, as well as potential therapeutic targets to inform the development and repurposing of drugs to reduce or prevent SVD, cognitive decline and vascular dementia. METHODS AND ANALYSIS: INSVD is a prospective observational multicentre cohort study in individuals with symptomatic SVD. This longitudinal study combines comprehensive immunophenotyping of the peripheral blood immune compartment with advanced neuroimaging markers of SVD and BBB permeability. The main SVD marker of interest is white matter microstructure as determined by diffusion tensor imaging, a valuable marker of disease progression owing to its sensitivity to early alterations to white matter integrity. The research is being conducted in two sites-in the UK (Cambridge) and the Netherlands (Nijmegen)-with each site recruiting 100 participants (total n=200). Participants undergo clinical and cognitive assessments, blood draws, and brain MRI at baseline and 2-year follow-up. ETHICS AND DISSEMINATION: This study received ethical approval from the local ethics boards (UK: East of England-Cambridge Central Research Ethics Committee (REC) ref: 22/EE/00141, Integrated Research Application System (IRAS) ID: 312 747. Netherlands: Medical Research Ethics Committee (MREC) Oost-Nederland, ref: 2022-13623, NL-number: NL80258.091.22). Written informed consent was obtained from all subjects before the study. Any participant-derived benefits resulting from this research, such as new insights into disease mechanisms or possible novel therapies, will be disseminated to study participants, patient groups and members of the public. TRIAL REGISTRATION NUMBER: NCT05746221.

Indexed as

Cerebral Small Vessel DiseasesDiffusion Tensor ImagingBlood-Brain BarrierCohort StudiesDisease ProgressionHumansInflammationLongitudinal StudiesMagnetic Resonance ImagingMulticenter Studies as TopicObservational Studies as TopicProspective StudiesAgedIMMUNOLOGYMagnetic resonance imagingOld age psychiatryStroke

Identifiers

PMID38413153
PMCPMC10900331
OpenAlexW4392202542

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.