Acute Ischemic StrokeNCT02798770
Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 337 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to Nov 2017
- How long will I take part?
- 5 Days
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.
Who may be able to join
- Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.
Who cannot join
- Patient not able to answer the in-person, bedside questionnaire asked by a trained study Nurse.
- Patient not willing to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke: a Prospective Cohort Study
Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window, however, the benefit of treatment strongly decreases as time passes.
Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the community on the symptom of stroke, prehospital delay did not decrease over time, and the reasons remain incompletely understood. Prehospital delay reduces the proportion of patients with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among the minority treated with thrombolysis.
This prospective cohort study aims at understanding the causes of prehospital delay among patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside, patients and proxies along a standardized questionnaire on prehospital delay. Avoiding modificables causes of prehospital delay may increase the thrombolysis rate and improve outcomes after stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- No Intervention Foreseen
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention ForeseenOther
| Study group | Role | What they receive |
|---|---|---|
| Stroke Center Basel | Not described Receives: Other: No Intervention Foreseen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prehospital Delay between between Stroke Onset and Admission to the Hospital as assessed by In-Person Interview
Prehospital delay will be assessed by asking the Patient or witnesses how long the time interval between stroke onset and Hospital Admission is. For instance, if stroke symptoms have onset today at 3:00 PM and the Patient gets admitted today at 4:00 PM, prehospital delay is 1 hour.
Measured: an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2017
- Study completionNov 2017
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 Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Marco De Marchis, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798770
- Sponsor's protocol ID
- UBE-15/64
- Status last verified
- Oct 2018
- First submitted
- 2 Jun 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Ready to share/pool data. The plan to make individual participant data has to be elaborated with the interested Party.
Publications
Fladt J, Meier N, Thilemann S, Polymeris A, Traenka C, Seiffge DJ, Sutter R, Peters N, Gensicke H, Fluckiger B, de Hoogh K, Kunzli N, Bringolf-Isler B, Bonati LH, Engelter ST, Lyrer PA, De Marchis GM. Reasons for Prehospital Delay in Acute Ischemic Stroke. J Am Heart Assoc. 2019 Oct 15;8(20):e013101. doi: 10.1161/JAHA.119.013101. Epub 2019 Oct 2.
PubMed 31576773
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02798770
- Acronym / sponsor ID
- UBE-15/64
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window, however, the benefit of treatment strongly decreases as time passes.
Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the community on the symptom of stroke, prehospital delay did not decrease over time, and the reasons remain incompletely understood. Prehospital delay reduces the proportion of patients with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among the minority treated with thrombolysis.
This prospective cohort study aims at understanding the causes of prehospital delay among patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside, patients and proxies along a standardized questionnaire on prehospital delay. Avoiding modificables causes of prehospital delay may increase the thrombolysis rate and improve outcomes after stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Center Basel | – | Other: No Intervention Foreseen |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.
Key inclusion criteria (1 listed)
- Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel.
Key exclusion criteria (2 listed)
- Patient not able to answer the in-person, bedside questionnaire asked by a trained study Nurse.
- Patient not willing to participate to the 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 |
|---|---|---|
| No Intervention Foreseen | Other | Stroke Center Basel |
Primary outcome
Prehospital Delay between between Stroke Onset and Admission to the Hospital as assessed by In-Person Interview
Time frame: an average of 1 hour
Prehospital delay will be assessed by asking the Patient or witnesses how long the time interval between stroke onset and Hospital Admission is. For instance, if stroke symptoms have onset today at 3:00 PM and the Patient gets admitted today at 4:00 PM, prehospital delay is 1 hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Derived from this study: PubMed 31576773Fladt J, Meier N, Thilemann S, Polymeris A, Traenka C, Seiffge DJ, Sutter R, Peters N, Gensicke H, Fluckiger B, de Hoogh K, Kunzli N, Bringolf-Isler B, Bonati LH, Engelter ST, Lyrer PA, De Marchis GM. Reasons for Prehospital Delay in Acute Ischemic Stroke. J Am Heart Assoc. 2019 Oct 15;8(20):e013101. doi: 10.1161/JAHA.119.013101. Epub 2019 Oct 2.
- Individual participant dataSharing planned: Yes. Ready to share/pool data. The plan to make individual participant data has to be elaborated with the interested Party.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prehospital Delay between between Stroke Onset and Admission to the Hospital as assessed by In-Person Interview (time frame: an average of 1 hour). 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 NCT02798770, 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 10 Oct 2018.