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

Study Overview
=================
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.

Detailed 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).

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Group 1


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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<br> <br> * Other names: Group 5;|
| Group 2<br>1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure | Other: Group 1<br> <br> * Other names: Group 5;|
| Group 3<br>Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis | Other: Group 1<br> <br> * Other names: Group 5;|
| Group 4<br>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<br> <br> * Other names: Group 5;|
| Group 5<br>Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure | Other: Group 1<br> <br> * Other names: Group 5;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke |  | Within 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute, informed consent, thrombolysis