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China Imaging-based Biobank of Cerebral Small Vessal Diseases

4. juli 2021 opdateret af: Peking University Third Hospital
The purpose of this study is to build a national image-based comprehensive evaluation platform of CSVD through longitudinal collection of imaging based medical data of patients with cerebral small vessel diseases (CSVD). On this basis, the new classification and diagnostic criteria of CSVD are proposed, and the risk prediction model of CSVD is established. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to build a national image-based CSVD comprehensive evaluation platform by collecting the medical data of patients with cerebral small vessel diseases (CSVD) based on imaging longitudinally, and to evaluate the risk factors of each type of CSVD, as well as imaging signs, cognition, gait, autonomic nervous system and hemodynamics, sleep, sleep, and so on The outcome of emotion and fundus. In the fields of imaging, molecular and neurocognitive function, we explored the etiology and pathophysiological mechanism of CSVD, proposed new classification and diagnostic criteria of CSVD, and established the risk prediction model of CSVD. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population, in order to reduce the burden of CSVD in China in the future.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

10000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Peking University Third Hospital
        • Kontakt:

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Cerebral Small Vessal Diseases patients

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 18 years old

  2. SVD lesions can be seen on MRI of the head

    • White matter hyperintensity, Fazekas score ≥ 2
    • Fazekas=1 has more than 2 vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, smoking, and other vascular events except stroke).
    • Fazekas = 1 and combined with lacunar focus
    • Imaging findings suggest new subcortical lacunar infarction
  3. Daily life independence (MRS ≤ 2)
  4. Sign informed consent

Note: the imaging definition of small vessel disease refers to the strong guideline

  1. The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions.
  2. New subcortical lacunar infarction: head MRI examination, subcortical, basal ganglia or brain stem DWI showed high signal (ADC diffusion limited) lesions with diameter < 20 mm, with or without corresponding clinical symptoms; There were new clinical symptoms. FLAIR sequence of head MRI showed flair hyperintense lesions (diameter < 20 mm) in subcortical, basal ganglia or pons.

Exclusion Criteria:

  1. In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm
  2. Acute cerebral hemorrhage

  3. Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage,

    Or untreated aneurysms (> 3mm in diameter) were found

  4. Neurodegenerative diseases, such as AD and PD, have been diagnosed

  5. There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy

    Diseases, etc

  6. Mental disorders diagnosed according to DSM-V diagnostic criteria
  7. Contraindications of MRI examination (such as claustrophobia)
  8. With severe organic diseases, such as malignant tumor, the expected survival time is less than 5 years
  9. Due to geographical or other reasons can not cooperate to complete the follow-up
  10. Patients also participated in other clinical trials

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
Intervention / Behandling
Cerebral Small Vessel Diseases group
CSVD patients
Andet: Ingen indgriben
Ingen indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients with each diagnosis.
Tidsramme: At discharge, usually within two weeks.
Detailed diagnosis of the patient's disease.
At discharge, usually within two weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mRS score
Tidsramme: during 5 years after diagnosis
mRS score of patients
during 5 years after diagnosis
New adverse vascular events
Tidsramme: during 5 years after diagnosis
New adverse vascular events
during 5 years after diagnosis

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University Third Hospital

Samarbejdspartnere

Beijing Tiantan Hospital

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)

1. oktober 2020

Primær færdiggørelse (Forventet)

31. december 2025

Studieafslutning (Forventet)

31. december 2026

Datoer for studieregistrering

Først indsendt

27. juni 2021

Først indsendt, der opfyldte QC-kriterier

4. juli 2021

Først opslået (Faktiske)

14. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M2021248

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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