NCT03941249

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

5.5 years

First QC Date

December 4, 2017

Last Update Submit

March 27, 2022

Conditions

Stroke

Keywords

MetabolomicsTauIschemic strokeHemorrhagic stroke

Outcome Measures

Primary Outcomes (1)

  • Ischemic or hemorrhagic stroke

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

    Within 7 days

Secondary Outcomes (4)

  • The extend of the brain damage

    Within 7 days

  • The extend of the physical damage

    Within 7 days

  • Etiology of stroke

    Within 7 days

  • Stroke patient or healthy subject

    Within 7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical stroke

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup Municipality, 2600, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blodsampels

MeSH Terms

Conditions

StrokePick Disease of the BrainIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesFrontotemporal DementiaFrontotemporal Lobar DegenerationDementiaNeurocognitive DisordersMental Disorders

Study Officials

  • Helle K Iversen, MD, DMSc

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, DmSc, head of the stroke unit

Study Record Dates

First Submitted

December 4, 2017

First Posted

May 7, 2019

Study Start

November 1, 2017

Primary Completion

April 30, 2023

Study Completion

December 1, 2023

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

DK(1)