- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03941249
Blod Biomarkers for Stroke
Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Glostrup, Denmark, 2600
- Department of clinical stroke research, department of neurology, Glostrup Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ischemic or hemorrhagic stroke
Time Frame: Within 7 days
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We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
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Within 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The extend of the brain damage
Time Frame: Within 7 days
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The relation between the biomarkers and brain damage measured by MRI.
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Within 7 days
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The extend of the physical damage
Time Frame: Within 7 days
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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
Time Frame: Within 7 days
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The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
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Within 7 days
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Stroke patient or healthy subject
Time Frame: Within 7 days
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The relation between the biomarkers and healthy subjects.
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Within 7 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Helle K Iversen, MD, DMSc, Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-15021321
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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