Cerebrovascular EventPIVA-SMSNCT07601659
Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke
An observational study of Cerebrovascular Event and Acute Ischemic Stroke, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The overall objective of the study is to prospectively validate the diagnostic accuracy of the Stroke Mimics Score (SMS). This score is calculated using information collected at the time of the patient's arrival in the Emergency Department (triage) and may assist clinicians in distinguishing between: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Event, Acute Ischemic Stroke, Intracerebral Hemorrhage
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 presenting to the Emergency Department with suspected acute stroke during the enrollment period. The final discharge diagnosis will serve as the gold standard.
Who may be able to join
- Age ≥ 18 years at the time of presentation to the Emergency Department.
- Presentation to the Emergency Department with a clinical suspicion of acute stroke, identified at nursing triage and/or through activation of the stroke pathway.
- Presentation to the Emergency Department during the 6-month prospective enrollment period.
- Feasibility of real-time collection of the data required to calculate the Stroke Mimics Score (SMS), including:
- age, systolic blood pressure, presence/absence of seizure at onset, presence/absence of headache at onset, presence/absence of confusion at onset, presence/absence of syncope at onset, presence/absence of isolated sensory deficit, presence/absence of motor deficit, history of coronary artery disease, history of prior stroke or transient ischemic attack (TIA).
- Availability of a final hospital discharge diagnosis at the end of hospitalization or Emergency Department observation.
- Signed informed consent from the patient or caregiver. If the patient is unconscious upon arrival at the Emergency Department, deferred consent will be applied.
Who cannot join
- Age < 18 years.
- Inability to fully collect the data required to calculate the Stroke Mimics Score (SMS).
- Absence of a clearly defined final hospital discharge diagnosis.
- Voluntary discharge, transfer, or death before completion of the diagnostic workup, in the absence of a reliable diagnosis.
- Repeated Emergency Department visits for the same clinical event (only the first visit will be considered).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Italian Multicenter Study for the Validation of the Stroke Mimics Score (SMS) in Patients With Suspected Acute Stroke
The overall objective of the study is to prospectively validate the diagnostic accuracy of the Stroke Mimics Score (SMS). This score is calculated using information collected at the time of the patient's arrival in the Emergency Department (triage) and may assist clinicians in distinguishing between:
- cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack [TIA]),
- stroke mimics (i.e., conditions that present with stroke-like symptoms but without actual infarction of brain tissue).
Read more
In addition, the study aims to compare its results with other existing tools and to evaluate its performance across different patient groups.
Specifically, the present research seeks to generate data on the reliability of the SMS tool in providing an accurate diagnosis.
- Conditions
- Cerebrovascular Event, Acute Ischemic Stroke, Intracerebral Hemorrhage, TIA (Transient Ischemic Attack), Stroke
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Ischemic Attack, Transient, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of accuracy of Stroke Mimics Score (SMS)
Diagnostic accuracy of the Stroke Mimics Score (SMS) in discriminating between:
- cerebrovascular events (CVE),
- stroke mimics (SM), assessed by:
Area Under the Receiver Operating Characteristic Curve (AUROC). The AUROC will be calculated with a 95% confidence interval. An AUROC value significantly higher than 0.70 will be considered indicative of an acceptable discriminative ability of the score.
Measured: through study completion, about 1 year
Secondary outcomes (1)
Analyses across clinical subgroups
To evaluate sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), score calibration, the performance of the grouped version (SMSg), comparison with FABS and TMS, and analyses across clinical subgroups.
Measured: through study completion, about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular EventStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frisullo Giovanni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giovanni Frisullo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601659
- Sponsor's protocol ID
- 27115
- Acronym
- PIVA-SMS
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Italian Multicenter Study for the Validation of the Stroke Mimics Score (SMS) in Patients With Suspected Acute Stroke
- ClinicalTrials.gov ID
- NCT07601659
- Acronym / sponsor ID
- PIVA-SMS / 27115
- Conditions
- Cerebrovascular Event, Acute Ischemic Stroke, Intracerebral Hemorrhage, TIA (Transient Ischemic Attack), Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 May 2026 (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 overall objective of the study is to prospectively validate the diagnostic accuracy of the Stroke Mimics Score (SMS). This score is calculated using information collected at the time of the patient's arrival in the Emergency Department (triage) and may assist clinicians in distinguishing between:
- cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack [TIA]),
- stroke mimics (i.e., conditions that present with stroke-like symptoms but without actual infarction of brain tissue).
In addition, the study aims to compare its results with other existing tools and to evaluate its performance across different patient groups.
Specifically, the present research seeks to generate data on the reliability of the SMS tool in providing an accurate diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the Emergency Department with suspected acute stroke during the enrollment period. The final discharge diagnosis will serve as the gold standard.
Key inclusion criteria (7 listed)
- Age ≥ 18 years at the time of presentation to the Emergency Department.
- Presentation to the Emergency Department with a clinical suspicion of acute stroke, identified at nursing triage and/or through activation of the stroke pathway.
- Presentation to the Emergency Department during the 6-month prospective enrollment period.
- Feasibility of real-time collection of the data required to calculate the Stroke Mimics Score (SMS), including:
- age, systolic blood pressure, presence/absence of seizure at onset, presence/absence of headache at onset, presence/absence of confusion at onset, presence/absence of syncope at onset, presence/absence of isolated sensory deficit, presence/absence of motor deficit, history of coronary artery disease, history of prior stroke or transient ischemic attack (TIA).
Key exclusion criteria (5 listed)
- Age < 18 years.
- Inability to fully collect the data required to calculate the Stroke Mimics Score (SMS).
- Absence of a clearly defined final hospital discharge diagnosis.
- Voluntary discharge, transfer, or death before completion of the diagnostic workup, in the absence of a reliable diagnosis.
- Repeated Emergency Department visits for the same clinical event (only the first visit will be considered).
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
The rate of accuracy of Stroke Mimics Score (SMS)
Time frame: through study completion, about 1 year
Diagnostic accuracy of the Stroke Mimics Score (SMS) in discriminating between: 1. cerebrovascular events (CVE), 2. stroke mimics (SM), assessed by: Area Under the Receiver Operating Characteristic Curve (AUROC). The AUROC will be calculated with a 95% confidence interval. An AUROC value significantly higher than 0.70 will be considered indicative of an acceptable discriminative ability of the score.
1 secondary outcome
Analyses across clinical subgroups
Time frame: through study completion, about 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Giovanni Frisullo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Event and Acute Ischemic Stroke, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Frisullo (+393476612284, giovanni.frisullo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of accuracy of Stroke Mimics Score (SMS) (time frame: through study completion, about 1 year). 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 22 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.