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Cerebral Small Vessel Disease Progression Dependent on Stroke Type (ZMA_BIO)

20. mai 2026 oppdatert av: Johannes Dorst

Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study

The goal of this prospective, observational study is to understand if cerebral small vessel disease (CSVD) has different velocities and patterns of temporal development, dependent on a concurrent ischemic stroke. It focusses on adult patients with known or newly diagnosed CSVD on magnetic resonance imaging. The study will evaluate if blood based, in parts central nervous system specific protein markers, so called biomarkers, have an additional value reflecting the course of CSVD as defined per MRI assessments. Further patient-relevant endpoints include neuropsychological abilities, neurological functional outcomes, quality of life assessments, stroke recurrence risk.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

180

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Mona E Laible, MD
Telefonnummer: +49(0)7311770
E-post: mona.laible@uniklinik-ulm.de

Studiesteder

Tyskland
- Baden-Wurttemberg
  - Ulm, Baden-Wurttemberg, Tyskland, 89081
    - Rekruttering
    - University Hospital Ulm, Department of Neurology, Germany
    - Ta kontakt med:
      
      Mona E Laible, MD
      
      Telefonnummer: +49(0)731 1770
      
      E-post: mona.laible@uniklinik-ulm.de

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients with sporadic, non-genetic cerebral small vessel disease

Beskrivelse

Inclusion Criteria:

Age ≥ 18 years
Evidence of cerebral small vessel disease on brain MRI, defined as white matter hyperintensities (Fazekas grade 1-3)
Assignment to one of the following study groups based on MRI findings:
cerebral small vessel disease without evidence of an acute ischemic stroke
cerebral small vessel disease with acute lacunar ischemic stroke
cerebral small vessel disease with acute territorial ischemic stroke
Ability to provide written informed consent
Sufficient German language skills to understand study procedures and assessments

Exclusion Criteria:

Alternative plausible causes of white matter hyperintensities other than cerebral small vessel disease (e.g. inflammatory central nervous system disorders, leukodystrophies, brain tumors)
Known neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, other dementias)
Acute or recent traumatic brain injury
Contraindications to magnetic resonance imaging
Pregnancy or breastfeeding
Life expectancy of less than one year
Inability to comply with study procedures or follow-up visits

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Group 1 cerebral small vessel disease without current stroke
Group 2 cerebral small vessel disease with acute lacunar stroke
Group 3 cerebral small vessel disease with acute territorial stroke

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in White Matter Lesion Volume based on MRI measurements Tidsramme: 1 year	MRI: White Matter Lesion volume will be measured and compared over the study trajectory (baseline upon study termination) in mm3	1 year

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Changes of Blood Biomarkers Tidsramme: 1 year	Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml)	1 year
Occurrence of Cerebrovascular Events Tidsramme: 1 year	Cerebrovascular events during the follow-up period and their association with biomarker levels and MRI-based disease progression, defined as a binary outcome variable (e.g. for ischemic stroke, myocardial infarction, peripheral artery occlusion).	1 year
Changes in Neuropsychological Tests Tidsramme: 1 year	Neuropsychological assessment focussing on attention, executive function, visual and verbal primary and working memory, as well as visuospatial function. For interpretation of results, z-scores will be applicable, as they are normalized according to age. A z-score of 0 equals the mean result of the normative population. A positive value indicates the data point is above the mean (a better performance than the mean results of the normatove population), while a negative value is below the mean. A score of -1.5 means the patient is 1.5 standard deviations below the mean, while a +1.0 is one SD above.	1 year
Neurological Functional Abilities Tidsramme: 1 year	Using the modified Rankin Score (0-6, a higher score indicates a worse functional ability and an mRS of 6 indicates death)	1 year
Changes in Neurovascular Duplex/Dopplerultrasound Tidsramme: 1 year	Neurovascular Duplex/Dopplerultrasound of extra-/intracranial brain-supplying arteries: changes in Plaque diameters (mm), Intima-Media-Thickness (IMT in mm, a higher IMT is associated with a more severe disease stage)	1 year
Stroke Severity Tidsramme: 1 year	National Institutes of Stroke Health Scale (NIHSS, 0-42 points, a higher stroke indicates a more severe stroke)	1 year
Acitivies of Daily Living Tidsramme: 1 year	ADL Score according to Katz (0-6)	1 year
EQ5D-5L Tidsramme: 1 year	The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661	1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johannes Dorst

Etterforskere

Studiestol: Mona E Laible, MD, University Hospital Ulm, Germany

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. mars 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

13. april 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)