Condition or disease |
---|
Stroke |
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:
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 150 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 1 Day |
Official Title: | Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients. |
Actual Study Start Date : | November 1, 2017 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | December 1, 2022 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of clinical stroke research, department of neurology, Glostrup Hospital | |
Glostrup, Denmark, 2600 |
Principal Investigator: | Helle K Iversen, MD, DMSc | Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | December 4, 2017 | ||||
First Posted Date | May 7, 2019 | ||||
Last Update Posted Date | August 19, 2020 | ||||
Actual Study Start Date | November 1, 2017 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Ischemic or hemorrhagic stroke [ Time Frame: Within 7 days ] We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Blod Biomarkers for Stroke | ||||
Official Title | Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients. | ||||
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:
|
||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||
Target Follow-Up Duration | 1 Day | ||||
Biospecimen | Retention: Samples With DNA Description:
Blodsampels
|
||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers. | ||||
Condition | Stroke | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
150 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 1, 2022 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Denmark | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03941249 | ||||
Other Study ID Numbers | H-15021321 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Helle Klingenberg Iversen, MD, DmSc, Glostrup University Hospital, Copenhagen | ||||
Study Sponsor | Helle Klingenberg Iversen, MD, DmSc | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | Glostrup University Hospital, Copenhagen | ||||
Verification Date | August 2020 |