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Blod Biomarkers for Stroke

27. marts 2022 opdateret af: Helle Klingenberg Iversen, MD, DmSc

Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.

The purpose of the project is to investigate specific markers in blood samples from patients with stroke (ischemic or hemorrhagic). This could hopefully help in the early diagnostic to separate patients with ischemic stroke from those with hemorrhagic stroke as treatment are different and patients need to come quickly to the correct treatment site.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

Approximately 12,000 Danes suffer a stroke each year with major consequences for those affected, their relatives and society in general. Rapid diagnosis and treatment mean less brain damage and thus less risk of late sequelae. A marker in the blood that is specific for stroke could result in faster diagnose and thereby treatment. Until now, no such marker has been found, but measurement of the so-called metabolomics and different fragments of brain proteins like Tau has shown promising results. Currently, metabolomics has only been studied in two other projects in stroke patients, and the results were not complete and a subtype of Tau (Tau-C) has been shown to be related to brain damage after ice hockey, but this is not studied in stroke patients, so there is a need for more studies.

In this project different fragments of brain proteins and the so-called metabolomics in the blood, which are small residues from the biological processes that take place in the body, such as fat and sugar incineration, will be studied.

The project is based on blood samples from a biobank that has been established in connection with previous projects in the Stroke Unit, Neurological Clinic, Rigshospitalet, Glostrup. All subjects have given written consent to give blood for future research.

Fifty microliters of blood from each participant will be analyzed by so-called mass spectroscopy, a well-researched method and performed in a recognized laboratory using known libraries and databases of metabolites for the determination and ongoing quality control. In addition, 250 microliters of serum will be analyzed by Elisa to detect brain proteins like Tau and Brevican.

The metabolomic profile and the brain proteins is compared to the information we have about the participants, namely:

  • If they had ischemic or hemorrhagic stroke or if it is a healthy control person
  • The extent of brain damage; partly measured by the brain scan and partly from the patient's symptoms
  • The cause of the stroke

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

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

Studiesteder

      • Glostrup, Danmark, 2600
        • Department of clinical stroke research, department of neurology, Glostrup Hospital

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

Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers.

Beskrivelse

Inclusion Criteria:

  • Clinical stroke

Exclusion Criteria:

  • Glasgow Coma Scale (GCS) < 15
  • Non communicating patients e.g. aphasia (incompetent patients)
  • Unable to cooperate to the physical examinations
  • Pregnancy or nursing mothers
  • If the investigators find the study participant unfit to conduct the investigations

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tværsnit

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ischemic or hemorrhagic stroke
Tidsramme: Within 7 days
We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
Within 7 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The extend of the brain damage
Tidsramme: Within 7 days
The relation between the biomarkers and brain damage measured by MRI.
Within 7 days
The extend of the physical damage
Tidsramme: Within 7 days
The relation between the biomarkers and brain damage measured by NIHSS.
Within 7 days
Etiology of stroke
Tidsramme: Within 7 days
The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
Within 7 days
Stroke patient or healthy subject
Tidsramme: Within 7 days
The relation between the biomarkers and healthy subjects.
Within 7 days

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Helle K Iversen, MD, DMSc, Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup

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. november 2017

Primær færdiggørelse (Forventet)

30. april 2023

Studieafslutning (Forventet)

1. december 2023

Datoer for studieregistrering

Først indsendt

4. december 2017

Først indsendt, der opfyldte QC-kriterier

6. maj 2019

Først opslået (Faktiske)

7. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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