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NCT03246256 Clinical Trial

Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.

Stroke Clinical Trial

Official title:
Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03246256
Other study ID # EA4/140/16
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 21, 2016
Est. completion date June 2021

Study information
Verified date November 2020
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

The purpose of this prospective multi-center study is to investigate whether patients with acute ischaemic stroke are able to recall information given before providing informed consent to intravenous thrombolysis after the end of treatment. Patients with acute ischaemic stroke will be compared to a group of relatives who witnessed the informed consent procedure of a relative with acute ischaemic stroke, stroke patients who were not treated with intravenous thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 260
Est. completion date June 2021
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria (all): - age =18 years - able to give informed consent - ability to understand and read German - no prior i.v.-thrombolysis Additional inclusion criteria - patients with acute ischaemic stroke: - suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke - indication for intravenous thrombolysis Additional inclusion criteria - relatives: · relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure Additional inclusion criteria - stroke patients with a contraindication for thrombolysis: - ischaemic stroke (according to brain MRI or CT) - contraindication for intravenous thrombolysis Additional inclusion criteria - non-stroke patients: · present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany Exclusion criteria (all groups): - not able to give imformed consent or under legal supervision/guardianship - participation in an interventional study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Group 1

Locations
Country Name City State
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany Department of Neurology, University of Heidelberg Heidelberg
Germany Department of Neurology, University Hospital Leipzig Leipzig Saxonia
Germany Klinikum der Stadt Ludwigshafen a. Rh. Ludwigshafen am Rhein
Germany Department of Neurology, University Hospital Würzburg Würzburg Bavaria

Sponsors (3)
Lead Sponsor Collaborator
Charite University, Berlin, Germany Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Department of Neurology, Charité - Universitätsmedizin Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke Within 24 hours
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