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Trial record 5 of 232 for:    Recruiting, Not yet recruiting, Available Studies | "informed consent"

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

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ClinicalTrials.gov Identifier: NCT03246256
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Collaborators:
Department of Neurology, Charité - Universitätsmedizin Berlin, Germany
Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin
Information provided by (Responsible Party):
Karl Georg Haeusler, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment
Stroke Other: Group 1

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).

Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
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
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5

Group 2
1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5

Group 3
Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5

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
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5

Group 5
Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure
Other: Group 1
Other Names:
  • Group 2
  • Group 3
  • Group 4
  • Group 5




Primary Outcome Measures :
  1. Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke [ Time Frame: Within 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246256


Contacts
Contact: Karl Georg Häusler, MD +49 30 450 560 676 georg.haeusler@charite.de
Contact: Luzie K Koehler, MD +49 30 450 560 698 luzie.koehler@charite.de

Locations
Germany
Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin Recruiting
Berlin, Germany
Contact: Karl Georg Häusler, MD    +49 30 450 560 676    georg.haeusler@charite.de   
Contact: Luzie K. Koehler, MD    +49 30 450 560 698    luzie.koehler@charite.de   
Universitätsklinikum Frankfurt Recruiting
Frankfurt am Main, Germany
Contact: Waltraud Pfeilschifter, MD       waltraud.pfeilschifter@kgu.de   
Department of Neurology, University of Heidelberg Recruiting
Heidelberg, Germany
Contact: Timolaos Rizos, MD         
Klinikum der Stadt Ludwigshafen a. Rh. Recruiting
Ludwigshafen am Rhein, Germany
Contact: Frederick Palm, MD       PALMF@klilu.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Department of Neurology, Charité - Universitätsmedizin Berlin, Germany
Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin

Responsible Party: Karl Georg Haeusler, Consultant Neurologist, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03246256     History of Changes
Other Study ID Numbers: EA4/140/16
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karl Georg Haeusler, Charite University, Berlin, Germany:
acute
informed consent
thrombolysis

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases