Cerebral Small Vessel Disease Progression Dependent on Stroke Type (ZMA_BIO)
20. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Observationel
Tilmelding (Anslået)
180
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mona E Laible, MD
- Telefonnummer: +49(0)7311770
- E-mail: mona.laible@uniklinik-ulm.de
Studiesteder
-
-
Baden-Wurttemberg
-
Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekruttering
- University Hospital Ulm, Department of Neurology, Germany
-
Kontakt:
- Mona E Laible, MD
- Telefonnummer: +49(0)731 1770
- E-mail: mona.laible@uniklinik-ulm.de
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Mona E Laible, MD, University Hospital Ulm, Germany
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. marts 2026
Primær færdiggørelse (Anslået)
1. april 2028
Studieafslutning (Anslået)
1. april 2028
Datoer for studieregistrering
Først indsendt
13. april 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ZMA_BIO
- DRKS00038936 (Anden identifikator: German Clinical Trials Registry)
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