Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke (PIVA-SMS)

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:

1. cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack [TIA]),
2. 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 Overview

• Status: Not yet recruiting
• Conditions: Stroke; Acute Ischemic Stroke; Intracerebral Hemorrhage; TIA (Transient Ischemic Attack); Cerebrovascular Event

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Giovanni Frisullo; Phone Number: +393476612284; Email: giovanni.frisullo@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, about 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, about 1 year

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Giovanni Frisullo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Brain Ischemia; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Stroke; Ischemic Attack, Transient; Cerebral Hemorrhage
• Other Study ID Numbers: 27115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No