StrokeSCENENCT03181412
Stroke Cincinnati Prehospital Stroke Severity Scale Evaluation iN prEhospital
An observational study of Stroke, run by Hospices Civils de Lyon at 12 sites in France.
Trial summary
The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Questionnaire
- How many people
- 1,272 participants
- Where
- 12 sitesFrance
- Study dates
- 25 Jun 2018to 31 Jan 2022
- 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 stroke of the Rhone area after emergency medical services call
Who may be able to join
- Consecutive patients calling emergency medical services for suspected acute ischemic stroke
Who cannot join
- Symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Neurologie, Hôpital Neurologique - HCL
Bron
SAMU 69 , Hôpital Edouard Herriot
Lyon, 69003
Médecine d'urgence, Clinique de la Sauvegarde
Lyon
Médecine d'urgence, Hôpital de la Croix-Rousse - HCL
Lyon
Médecine d'urgence, Hôpital Desgenettes
Lyon
Médecine d'urgence, Hôpital Mutualiste Médipôle
Lyon
Médecine d'urgence, Hôpital Saint Joseph Saint Luc
Lyon
Urgentiste, Centre Hospitalier Lyon Sud
Pierre-Bénite
Médecine d'urgence, CH de Roanne
Roanne
Médecine d'urgence, Hôpital Nord-Ouest
Tarare
Services Médecine d'urgence et Neurologie, CH de Vienne
Vienne
Services Neurologie et Médecine d'urgence, CH de Villefranche sur Saône
Villefranche-sur-Saône
About this study
Official title: Evaluation of the Performances of the Cincinnati Prehospital Stroke Severity Scale Realized During Telephone Call With Emergency Department Physicians to Predict Large-vessel Occlusion
The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.
- Conditions
- Stroke
- Being tested
- Questionnaire
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDiagnostic test
Tests from Cincinnati prehospital stroke severity scale (CPSSS) will be carried out by the physician at emergency medical services on telephone call with firemen, paramedics or the emergency medical services team for any stroke suspicion that meets the criteria for inclusion. Emergency department physician will have to follow a standardized questionnaire to complete the different items of the score. The score will not be calculated by emergency department physician and will not influence the orientation and management of patients.
The final diagnosis will be the presence or absence of a large vessel occlusion. This diagnosis will be done on cerebral imaging by a neurologist.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected ischemic stroke | The cohort will be constituted of patients treated for a stroke suspicion after calling emergency medical services of the Rhone and presenting a symptom-onset (the last time the patient was seen without deficit) less than 6 hours. Receives: Diagnostic Test: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performances of Cincinnati prehospital stroke severity scale
The Cincinnati prehospital stroke severity scale is composed of 3 items: 2 points if the patient has a deviation of the gaze, 1 point if the patient is not able to give the date and answer to a simple order such as closing the eyes or clenching the fist and 1 point if the patient presents a hemiplegia. The CPSSS score ranges from 0 to 4, highest value indicating the worst score. It will be considered positive if it is equal to 2 or more.
Performances will be evaluated in terms of sensitivity, specificity, positive and negative predictive values.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start25 Jun 2018
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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
- Retrospective
- Enrolment
- 1,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181412
- Sponsor's protocol ID
- 69HCL17_0146
- Acronym
- SCENE
- Status last verified
- Nov 2022
- First submitted
- 7 Jun 2017
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performances of the Cincinnati Prehospital Stroke Severity Scale Realized During Telephone Call With Emergency Department Physicians to Predict Large-vessel Occlusion
- ClinicalTrials.gov ID
- NCT03181412
- Acronym / sponsor ID
- SCENE / 69HCL17_0146
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,272 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Jun 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 effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected ischemic stroke | – | Diagnostic Test: QuestionnaireThe cohort will be constituted of patients treated for a stroke suspicion after calling emergency medical services of the Rhone and presenting a symptom-onset (the last time the patient was seen without deficit) less than 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke of the Rhone area after emergency medical services call
Key inclusion criteria (1 listed)
- Consecutive patients calling emergency medical services for suspected acute ischemic stroke
Key exclusion criteria (1 listed)
- Symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours
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 |
|---|---|---|
| QuestionnaireTests from Cincinnati prehospital stroke severity scale (CPSSS) will be carried out by the physician at emergency medical services on telephone call with firemen, paramedics or the emergency medical services team for any stroke suspicion that meets the criteria for inclusion. Emergency department physician will have to follow a standardized questionnaire to complete the different items of the score. The score will not be calculated by emergency department physician and will not influence the orientation and management of patients. The final diagnosis will be the presence or absence of a large vessel occlusion. This diagnosis will be done on cerebral imaging by a neurologist. | Diagnostic test | Patients with suspected ischemic stroke |
Primary outcome
Performances of Cincinnati prehospital stroke severity scale
Time frame: 1 day
The Cincinnati prehospital stroke severity scale is composed of 3 items: 2 points if the patient has a deviation of the gaze, 1 point if the patient is not able to give the date and answer to a simple order such as closing the eyes or clenching the fist and 1 point if the patient presents a hemiplegia. The CPSSS score ranges from 0 to 4, highest value indicating the worst score. It will be considered positive if it is equal to 2 or more. Performances will be evaluated in terms of sensitivity, specificity, positive and negative predictive values.
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 21 Nov 2022.
- 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.
12 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 12 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 1 inclusion and 1 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Performances of Cincinnati prehospital stroke severity scale (time frame: 1 day). 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 21 Nov 2022.