StrokeNCT03246256
Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.
An observational study of Stroke, run by Charite University, Berlin, Germany at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Group 1
- Type of treatment
- Injection or infusion
- How many people
- 260 participants
- Where
- 5 sitesGermany
- Study dates
- 21 Dec 2016to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- not able to give imformed consent or under legal supervision/guardianship
- participation in an interventional study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Universitätsklinikum Frankfurt
Frankfurt am Main
Department of Neurology, University of Heidelberg
Heidelberg
Department of Neurology, University Hospital Leipzig
Leipzig, Saxony
Klinikum der Stadt Ludwigshafen a. Rh.
Ludwigshafen am Rhein
Department of Neurology, University Hospital Würzburg
Würzburg, Bavaria
About this study
Official title: Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.
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.
Read the 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).
- Conditions
- Stroke
- Being tested
- Group 1
- Keywords
- acute, informed consent, thrombolysis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
Also called Group 2, Group 3, Group 4, Group 5
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Group 1 | |
| Group 2 | 1st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure Receives: Other: Group 1 | |
| Group 3 | Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis Receives: 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) Receives: Other: Group 1 | |
| Group 5 | Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure Receives: Other: Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start21 Dec 2016
- Primary completionJun 2020
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Neurology, Charité - Universitätsmedizin Berlin, Germany, Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin
- Responsible party
- Principal investigator, Karl Georg Haeusler, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246256
- Sponsor's protocol ID
- EA4/140/16
- Status last verified
- Nov 2020
- First submitted
- 3 Aug 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37021170
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recall of Information on Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Given During Informed Consent: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03246256
- Acronym / sponsor ID
- EA4/140/16
- Conditions
- Stroke
- Keywords
- acute, informed consent, thrombolysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Department of Neurology, Charité - Universitätsmedizin Berlin, Germany, Department of Cardiology and Pneumology, Charité, Campus Benjamin Franklin
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Group 1Patients 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 |
| Group 2 | – | Other: Group 11st of 2nd degree relatives of patients with acute ischaemic stroke, who witnessed the informed consent procedure |
| Group 3 | – | Other: Group 1Stroke patients with acute or subacute ischaemic stroke with a contraindication for intravenous thrombolysis |
| Group 4 | – | Other: Group 1Patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany) |
| Group 5 | – | Other: Group 1Patients with acute ischaemic stroke who were administered intavenous thrombolysis - recall 24 hours after the informed consent procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- not able to give imformed consent or under legal supervision/guardianship
- participation in an interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1Also: Group 2, Group 3, Group 4, Group 5 | Other | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke
Time frame: Within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 37021170Schuster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Charite University, Berlin, Germany at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall of the designated facts given during informed consent procedure on intravenous thrombolysis after acute ischaemic stroke (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.