StrokeAIPONCT06427746
Enhancing Prehospital Stroke Diagnosis
An observational study of Stroke, run by Agenzia Regionale emergenza Urgenza at 1 site in Italy.
Trial summary
Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Standard, Video call and Video call + LARIO
- Type of treatment
- Surgery or procedure
- How many people
- 2,197 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 31 Aug 2024
- 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: Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area
Who may be able to join
- suspected stroke
- rescued by basic life support vehicle
- consciousness
- informed consent
Who cannot join
- age < 18 years
- rescued by an advanced life support vehicle
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
SOREU Metropolitana
Milan, 20100
Paola Manzoni, MD, 02 52872802, p.manzoni@areu.lombardia.it
Michela Generali, MD
About this study
Official title: Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting
Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:
- the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
- the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.
- Conditions
- Stroke
- Being tested
- Standard, Video call, Video call + LARIO
- Keywords
- stroke, video call
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardProcedure or surgery
Basic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home.
Video callProcedure or surgery
Among the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke.
Video call + LARIOProcedure or surgery
LARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room.
| Study group | Role | What they receive |
|---|---|---|
| Standard | stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers Receives: Procedure: Standard | |
| Video call | stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers during live video call with the healthcare personnel in EMS dispatch Receives: Procedure: Video call | |
| Video call + LARIO | stroke diagnosis in the pre-hospital settings, based on the CPSS + LARIO scales assessed by lay rescuers (with specific training on the 2 scales) during live video call with the healthcare personnel in EMS dispatch Receives: Procedure: Video call + LARIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of prehospital stroke diagnosis
Evaluate if the use of the video call with or without the assessment of the LARIO scale, between the prehospital lay rescuer and the medical dispatch improve the identification of stroke patients in comparison to the only CPSS scale evaluated by the lay rescuer. The diagnosis accuracy is evaluated by confirmation of stroke at the cerebral angio-CT scan
Measured: within 2 hours from hospital admission
Secondary outcomes (2)
Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels
LARIO is a stroke scale is a simple 5-item clinical scale that can be used to predict the presence of large vessel occlusion (LVO) in patients with acute ischemic stroke. A large vessel of the anterior cerebral circulation is defined as occlusion of the intracranial segment of the internal carotid artery, anterior cerebral artery segments A1 and A2, and middle cerebral artery segments M1 and M2. Final diagnosis is based on the cerebral angio CT scan
Measured: within 2 hours from hospital admission
incidence of hemorrhagic stroke
incidence of hemorrhagic stroke among patients identified as stroke patients. Diagnosis is based on the results of the cerebral CT
Measured: within 2 hours hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
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.
- 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
- 2,197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agenzia Regionale emergenza Urgenza
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anna Coppo, MD, Principal investigator, AREU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427746
- Sponsor's protocol ID
- AREU_A.I.P.O.
- Acronym
- AIPO
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting
- ClinicalTrials.gov ID
- NCT06427746
- Acronym / sponsor ID
- AIPO / AREU_A.I.P.O.
- Conditions
- Stroke
- Keywords
- stroke, video call
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,197 participants (estimated)
- Lead sponsor
- Agenzia Regionale emergenza UrgenzaOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 24 May 2024 (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.
Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:
- the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
- the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | – | Procedure: Standardstroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers |
| Video call | – | Procedure: Video callstroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers during live video call with the healthcare personnel in EMS dispatch |
| Video call + LARIO | – | Procedure: Video call + LARIOstroke diagnosis in the pre-hospital settings, based on the CPSS + LARIO scales assessed by lay rescuers (with specific training on the 2 scales) during live video call with the healthcare personnel in EMS dispatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area
Key inclusion criteria (4 listed)
- suspected stroke
- rescued by basic life support vehicle
- consciousness
- informed consent
Key exclusion criteria (2 listed)
- age < 18 years
- rescued by an advanced life support vehicle
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 |
|---|---|---|
| StandardBasic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home. | Procedure or surgery | Standard |
| Video callAmong the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke. | Procedure or surgery | Video call |
| Video call + LARIOLARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room. | Procedure or surgery | Video call + LARIO |
Primary outcome
Accuracy of prehospital stroke diagnosis
Time frame: within 2 hours from hospital admission
Evaluate if the use of the video call with or without the assessment of the LARIO scale, between the prehospital lay rescuer and the medical dispatch improve the identification of stroke patients in comparison to the only CPSS scale evaluated by the lay rescuer. The diagnosis accuracy is evaluated by confirmation of stroke at the cerebral angio-CT scan
2 secondary outcomes
Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels
Time frame: within 2 hours from hospital admission
incidence of hemorrhagic stroke
Time frame: within 2 hours hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Anna Coppo, MD principal investigator
AREU
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 Stroke, run by Agenzia Regionale emergenza Urgenza at 1 site in Italy.
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 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 24 May 2024. 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 Italy. 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?
Contact Anna Coppo, MD (0267129001, a.coppo@areu.lombardia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of prehospital stroke diagnosis (time frame: within 2 hours from hospital admission). 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 24 May 2024.