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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03246256
Other study ID # EA4/140/16
Secondary ID
Status Recruiting
Phase N/A
First received August 3, 2017
Last updated August 10, 2017
Start date December 21, 2016
Est. completion date December 2018

Study information

Verified date August 2017
Source Charite University, Berlin, Germany
Contact Karl Georg Häusler, MD
Phone +49 30 450 560 676
Email georg.haeusler@charite.de
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 Recruiting
Enrollment 260
Est. completion date December 2018
Est. primary completion date December 2018
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 Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin Berlin
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany Department of Neurology, University of Heidelberg Heidelberg
Germany Klinikum der Stadt Ludwigshafen a. Rh. Ludwigshafen am Rhein

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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