Blod Biomarkers for Stroke
- Conditions
- Stroke
- Registration Number
- NCT03941249
- Lead Sponsor
- Helle Klingenberg Iversen, MD, DmSc
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Clinical stroke
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ischemic or hemorrhagic stroke Within 7 days We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
- Secondary Outcome Measures
Name Time Method The extend of the brain damage Within 7 days The relation between the biomarkers and brain damage measured by MRI.
The extend of the physical damage Within 7 days The relation between the biomarkers and brain damage measured by NIHSS.
Etiology of stroke Within 7 days The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
Stroke patient or healthy subject Within 7 days The relation between the biomarkers and healthy subjects.
Trial Locations
- Locations (1)
Department of clinical stroke research, department of neurology, Glostrup Hospital
🇩🇰Glostrup, Denmark