StrokeSTROKE 69NCT02596607
Study of the Performance of Stroke Management in the Rhône Area
An observational study of Stroke, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 3,454 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Nov 2015to 31 Dec 2017
- 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: Consecutive patients treated for a stroke suspicion at the acute phase
Who may be able to join
- Consecutive patients treated for a stroke suspicion at the acute phase ,
- with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
- Managed by the SAMU centre 15, in one of the emergency unit or stroke unit of the Rhône area
- Regardless of their geographical origin
Who cannot join
- Age under 18 years
- Symptom onset exceeding 24 hours
- Stroke during hospitalization
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Department of stroke unit - Hospices Civils de Lyon
Bron, 69500
Hôpital Desgenettes
Bron
Hôpital de la Croix Rousse
Lyon
Hôpital St Joseph St Luc
Lyon
Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot
Lyon
Centre Hospitalier Lyon Sud
Pierre-Bénite
CH Villefranche
Villefranche-sur-Saône
About this study
Official title: Study of the Performance of Acute Stroke Management in the Rhône Area After Implementation of a Multi-action Program
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).
The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.
Read more
The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.
The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.
After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.
AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.
- Conditions
- Stroke
- Keywords
- ischemic stroke, acute phase, thrombolysis, management times
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra -hospital management times
- Admission - brain imaging time
- Admission- arrival at stroke unit time
- Brain imaging time - arrival at stroke unit time
- Admission period - thrombolysis time (door-to-needle time)
Measured: 24h
Secondary outcomes (6)
Assessment of the overall impact of actions on patients management
Proportion of patients thrombolysed, proportion of cerebral hemorrhage after thrombolysis, proportion of patients treated by thrombectomy
Measured: 24h
Assessment of the impact of public campaigns
Pre-hospital time: symptoms onset- hospital admission time (admission in stroke unit or emergency unit), time from symptom onset to call to SAMU centre 15
Measured: 24h
Assessment of the impact of the increase of stroke unit beds
Proportion of patients managed in stroke unit at acute phase
Measured: 48h
Assessment of the impact of training of SAMU centre 15 professionals and firefighters on stroke detection
Proportion of patients managed by fast-track (direct admission in stroke unit after call to SAMU centre 15), proportion of patients managed by the SAMU centre 15
Measured: 24h
Assessment of the impact of the implementation of telemedicine
Proportion of patients thrombolysed in emergency unit via telemedicine / stroke unit / critical care unit )
Measured: 24h
Assessment of the impact of the actions on the prognosis of patients
Proportion of patients who died during the initial hospitalization, proportion of patients who died at 3 and 12 months, proportion of patients with disabilities at 3 and 12 months evaluated by the Modified Rankin Scale and by the Barthel Index among patients with a confirmed diagnosis of stroke or TIA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start6 Nov 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 3,454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent DEREX, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596607
- Sponsor's protocol ID
- 69HCL15_0076
- Acronym
- STROKE 69
- Status last verified
- Feb 2018
- First submitted
- 3 Nov 2015
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Performance of Acute Stroke Management in the Rhône Area After Implementation of a Multi-action Program
- ClinicalTrials.gov ID
- NCT02596607
- Acronym / sponsor ID
- STROKE 69 / 69HCL15_0076
- Conditions
- Stroke
- Keywords
- ischemic stroke, acute phase, thrombolysis, management times
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,454 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 Nov 2015 (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.
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).
The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.
The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.
The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.
After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.
AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients treated for a stroke suspicion at the acute phase
Key inclusion criteria (4 listed)
- Consecutive patients treated for a stroke suspicion at the acute phase ,
- with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
- Managed by the SAMU centre 15, in one of the emergency unit or stroke unit of the Rhône area
- Regardless of their geographical origin
Key exclusion criteria (3 listed)
- Age under 18 years
- Symptom onset exceeding 24 hours
- Stroke during hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra -hospital management times
Time frame: 24h
* Admission - brain imaging time * Admission- arrival at stroke unit time * Brain imaging time - arrival at stroke unit time * Admission period - thrombolysis time (door-to-needle time)
6 secondary outcomes
Assessment of the overall impact of actions on patients management
Time frame: 24h
Assessment of the impact of public campaigns
Time frame: 24h
Assessment of the impact of the increase of stroke unit beds
Time frame: 48h
Assessment of the impact of training of SAMU centre 15 professionals and firefighters on stroke detection
Time frame: 24h
Assessment of the impact of the implementation of telemedicine
Time frame: 24h
Assessment of the impact of the actions on the prognosis of patients
Time frame: 12 months
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 7 Feb 2018.
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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.
Laurent DEREX, MD principal investigator
Hospices Civils de Lyon
7 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 Hospices Civils de Lyon at 7 sites in France.
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 4 inclusion and 3 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Intra -hospital management times (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2018.