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出境医 / 临床实验 / Blod Biomarkers for Stroke

Blod Biomarkers for Stroke

Study Description
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.

Condition or disease
Stroke

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
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Ischemic or hemorrhagic stroke [ Time Frame: Within 7 days ]
    We hope to find a method to differentiate between ischemic and hemorrhagic stroke.


Secondary Outcome Measures :
  1. The extend of the brain damage [ Time Frame: Within 7 days ]
    The relation between the biomarkers and brain damage measured by MRI.

  2. The extend of the physical damage [ Time Frame: Within 7 days ]
    The relation between the biomarkers and brain damage measured by NIHSS.

  3. Etiology of stroke [ Time Frame: Within 7 days ]
    The relation between the biomarkers and stroke etiology measured by the TOAST criteria.

  4. Stroke patient or healthy subject [ Time Frame: Within 7 days ]
    The relation between the biomarkers and healthy subjects.


Biospecimen Retention:   Samples With DNA
Blodsampels

Eligibility Criteria
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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
Study Population
Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers.
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
Contacts and Locations

Locations
Layout table for location information
Denmark
Department of clinical stroke research, department of neurology, Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Helle Klingenberg Iversen, MD, DmSc
Investigators
Layout table for investigator information
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
 (submitted: May 6, 2019)
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
 (submitted: May 6, 2019)
  • The extend of the brain damage [ Time Frame: Within 7 days ]
    The relation between the biomarkers and brain damage measured by MRI.
  • The extend of the physical damage [ Time Frame: Within 7 days ]
    The relation between the biomarkers and brain damage measured by NIHSS.
  • Etiology of stroke [ Time Frame: Within 7 days ]
    The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
  • Stroke patient or healthy subject [ Time Frame: Within 7 days ]
    The relation between the biomarkers and healthy subjects.
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:

  • 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 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
 (submitted: May 6, 2019)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Helle K Iversen, MD, DMSc Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
PRS Account Glostrup University Hospital, Copenhagen
Verification Date August 2020