NCT03246256

Brief Summary

The aim of the study is to investigate the ability to recall information given during informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.

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
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

December 21, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.4 years

First QC Date

August 3, 2017

Last Update Submit

November 10, 2020

Conditions

Stroke

Keywords

acuteinformed consentthrombolysis

Outcome Measures

Primary Outcomes (1)

  • Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke

    Within 24 hours

Study Arms (5)

Group 1

Patients with acute ischaemic stroke who were administered intavenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis; recall in both cases 60 to 90 minutes after the informed consent procedure

Other: Group 1

Group 2

1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure

Other: Group 1

Group 3

Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis

Other: Group 1

Group 4

Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany)

Other: Group 1

Group 5

Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure

Other: Group 1

Interventions

Group 1OTHER
Also known as: Group 2, Group 3, Group 4, Group 5
Group 1Group 2Group 3Group 4Group 5

Eligibility Criteria

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

Patients with acute ischaemic stroke and intravenous thrombolysis or patients with acute ischaemic stroke refusing intravenous thrombolysis, relatives (1st or 2nd degree) of patients with acute ischaemic stroke, patient with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis and patients without acute ischaemic stroke (admitted to the Department of Cardiology (Charité, Campus Benjamin Franklin, Germany).

You may qualify if:

  • age ≥18 years
  • able to give informed consent
  • ability to understand and read German
  • no prior i.v.-thrombolysis
  • suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke
  • indication for intravenous thrombolysis
  • · relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure
  • ischaemic stroke (according to brain MRI or CT)
  • contraindication for intravenous thrombolysis
  • · present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany

You may not qualify if:

  • not able to give imformed consent or under legal supervision/guardianship
  • participation in an interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Neurology, University Hospital Würzburg

Würzburg, Bavaria, Germany

Location

Department of Neurology, University Hospital Leipzig

Leipzig, Saxony, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Location

Department of Neurology, University of Heidelberg

Heidelberg, Germany

Location

Klinikum der Stadt Ludwigshafen a. Rh.

Ludwigshafen am Rhein, Germany

Location

Related Publications (1)

  • Schuster L, Essig F, Daneshkhah N, Herm J, Hellwig S, Endres M, Dirnagl U, Hoffmann F, Michalski D, Pfeilschifter W, Urbanek C, Petzold GC, Rizos T, Kraft A, Haeusler KG. Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study. Eur Stroke J. 2023 Mar;8(1):241-250. doi: 10.1177/23969873221143856. Epub 2023 Jan 6.

    PMID: 37021170DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurologist

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 11, 2017

Study Start

December 21, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)