Clinical trial NCT03941249: Blod Biomarkers for Stroke
Official title: Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Metabolomics
Tau
Ischemic stroke
Hemorrhagic stroke
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Ischemic or hemorrhagic stroke
timeFrame: Within 7 days
Secondary outcomes:
measure: The extend of the brain damage
timeFrame: Within 7 days
measure: The extend of the physical damage
timeFrame: Within 7 days
measure: Etiology of stroke
timeFrame: Within 7 days
measure: Stroke patient or healthy subject
timeFrame: Within 7 days
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of clinical stroke research, department of neurology, Glostrup Hospital
Study officials:
affiliation: Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
name: Helle K Iversen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: