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New score could help ER doctors spot fake strokes faster

NCT ID NCT07601659

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a new tool called the Stroke Mimics Score (SMS) in 1000 adults who come to the emergency room with stroke-like symptoms. The goal is to see if the SMS can accurately tell the difference between a real stroke and a condition that looks like a stroke but isn't (a stroke mimic). Researchers will compare the SMS to other existing tools and check how well it works in different patient groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this tool could help emergency doctors quickly and accurately decide whether a patient is having a stroke or a stroke mimic, leading to faster, more appropriate care.
What could go wrong
This is an observational study, not a treatment trial. The tool may not prove accurate enough in real-world settings, and results may not apply to all hospitals or patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage ischemic stroke stroke disorder transient ischemic attack

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke Cerebrovascular event Intracerebral hemorrhage Stroke Tia (transient ischemic attack)

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.