Clincosm LogoSign in Get a demo

Blod Biomarkers for Stroke

Sponsor
Helle Klingenberg Iversen, MD, DmSc (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03941249
Collaborator
(none)
150
Enrollment
1
Location
73
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
    Actual Study Start Date :
    Nov 1, 2017
    Anticipated Primary Completion Date :
    Apr 30, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Ischemic or hemorrhagic stroke [Within 7 days]

      We hope to find a method to differentiate between ischemic and hemorrhagic stroke.

    Secondary Outcome Measures

    1. The extend of the brain damage [Within 7 days]

      The relation between the biomarkers and brain damage measured by MRI.

    2. The extend of the physical damage [Within 7 days]

      The relation between the biomarkers and brain damage measured by NIHSS.

    3. Etiology of stroke [Within 7 days]

      The relation between the biomarkers and stroke etiology measured by the TOAST criteria.

    4. Stroke patient or healthy subject [Within 7 days]

      The relation between the biomarkers and healthy subjects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of clinical stroke research, department of neurology, Glostrup Hospital Glostrup Denmark 2600

    Sponsors and Collaborators

    • Helle Klingenberg Iversen, MD, DmSc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helle Klingenberg Iversen, MD, DmSc, MD, DmSc, head of the stroke unit, Glostrup University Hospital, Copenhagen
    ClinicalTrials.gov Identifier:
    NCT03941249
    Other Study ID Numbers:
    • H-15021321
    First Posted:
    May 7, 2019
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Helle Klingenberg Iversen, MD, DmSc, MD, DmSc, head of the stroke unit, Glostrup University Hospital, Copenhagen
    Metabolomics
    Tau
    Ischemic stroke
    Hemorrhagic stroke
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Mar 29, 2022