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

20 maj 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

180

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / 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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Changes of Blood Biomarkers Tidsram: 1 year	Changes in blood biomarkers (e.g. NfL, GFAP, pTau in pg/ml)	1 year
Occurrence of Cerebrovascular Events Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 1 year	ADL Score according to Katz (0-6)	1 year
EQ5D-5L Tidsram: 1 year	The EQ5D-5L ranges from a maximum of 1 (full health) to a minimum of roughly -0.661	1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johannes Dorst

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 mars 2026

Primärt slutförande (Beräknad)

1 april 2028

Avslutad studie (Beräknad)

1 april 2028

Studieregistreringsdatum

Först inskickad

13 april 2026

Först inskickad som uppfyllde QC-kriterierna

20 maj 2026

Första postat (Faktisk)

28 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)