Blod Biomarkers for Stroke

NCT ID: NCT03941249

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2023-12-01

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

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helle Klingenberg Iversen, MD, DmSc

OTHER

Sponsor Role: lead

Responsible Party

Helle Klingenberg Iversen, MD, DmSc

MD, DmSc, head of the stroke unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Helle K Iversen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup

Locations

Department of clinical stroke research, department of neurology, Glostrup Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

H-15021321

Identifier Type: -

Identifier Source: org_study_id