Blod Biomarkers for Stroke

March 27, 2022 updated by: Helle Klingenberg Iversen, MD, DmSc

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glostrup, Denmark, 2600
        • Department of clinical stroke research, department of neurology, Glostrup Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stroke patients admitted to the acute stroke unit at Rigshospitalet, Glostrup. Healthy volunteers.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
Within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extend of the brain damage
Time Frame: Within 7 days
The relation between the biomarkers and brain damage measured by MRI.
Within 7 days
The extend of the physical damage
Time Frame: Within 7 days
The relation between the biomarkers and brain damage measured by NIHSS.
Within 7 days
Etiology of stroke
Time Frame: Within 7 days
The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
Within 7 days
Stroke patient or healthy subject
Time Frame: Within 7 days
The relation between the biomarkers and healthy subjects.
Within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helle K Iversen, MD, DMSc, Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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