Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke

NCT07601659 | Not Yet Recruiting

• 1 other identifier: 27115
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack \[TIA\]),
2. 2.stroke mimics (i.e., conditions that present with stroke-like symptoms but without actual infarction of brain tissue).

Conditions

Cerebrovascular Event; Acute Ischemic Stroke; Intracerebral Hemorrhage; TIA (Transient Ischemic Attack); Stroke

Outcome Measures

Primary Outcomes (1)

• The rate of accuracy of Stroke Mimics Score (SMS)

  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.

  through study completion, about 1 year

Secondary Outcomes (1)

• Analyses across clinical subgroups

  through study completion, about 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia

Study Officials

• Giovanni Frisullo

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Frisullo

CONTACT

+393476612284; giovanni.frisullo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Neurologist

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05