StrokeNCT03941249
Blod Biomarkers for Stroke
An observational study of Stroke, run by Helle Klingenberg Iversen, MD, DmSc at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to 1 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers.
Who may be able to join
- Clinical stroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of clinical stroke research, department of neurology, Glostrup Hospital
Glostrup Municipality, 2600
About this study
Official title: Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
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.
Read the 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
- Conditions
- Stroke
- Keywords
- Metabolomics, Tau, Ischemic stroke, Hemorrhagic stroke
- Medical subject headings
- Stroke, Pick Disease of the Brain, Ischemic Stroke, Hemorrhagic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic or hemorrhagic stroke
We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
Measured: Within 7 days
Secondary outcomes (4)
The extend of the brain damage
The relation between the biomarkers and brain damage measured by MRI.
Measured: Within 7 days
The extend of the physical damage
The relation between the biomarkers and brain damage measured by NIHSS.
Measured: Within 7 days
Etiology of stroke
The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
Measured: Within 7 days
Stroke patient or healthy subject
The relation between the biomarkers and healthy subjects.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Nov 2017
- Primary completion30 Apr 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Helle Klingenberg Iversen, MD, DmSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helle Klingenberg Iversen, MD, DmSc, Glostrup University Hospital, Copenhagen
- Investigators
- Helle K Iversen, MD, DMSc, Principal investigator, Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941249
- Sponsor's protocol ID
- H-15021321
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
- ClinicalTrials.gov ID
- NCT03941249
- Acronym / sponsor ID
- H-15021321
- Conditions
- Stroke
- Keywords
- Metabolomics, Tau, Ischemic stroke, Hemorrhagic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Helle Klingenberg Iversen, MD, DmScUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers.
Key inclusion criteria (1 listed)
- Clinical stroke
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ischemic or hemorrhagic stroke
Time frame: Within 7 days
We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
4 secondary outcomes
The extend of the brain damage
Time frame: Within 7 days
The extend of the physical damage
Time frame: Within 7 days
Etiology of stroke
Time frame: Within 7 days
Stroke patient or healthy subject
Time frame: Within 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle K Iversen, MD, DMSc principal investigator
Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Helle Klingenberg Iversen, MD, DmSc at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic or hemorrhagic stroke (time frame: Within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.