- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03941249
Blod Biomarkers for Stroke
Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
Studieoversigt
Status
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
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Glostrup, Danmark, 2600
- Department of clinical stroke research, department of neurology, Glostrup Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
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.
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Within 7 days
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Etiology of stroke
Tidsramme: Within 7 days
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The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
|
Within 7 days
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Stroke patient or healthy subject
Tidsramme: Within 7 days
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The relation between the biomarkers and healthy subjects.
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Within 7 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Helle K Iversen, MD, DMSc, Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-15021321
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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