Clinical Trial

Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke

Study acronym: PIVA-SMS
Not Yet Recruiting
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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. 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.
Trial Details
NCT Number NCT07601659
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Cerebrovascular Event, Acute Ischemic Stroke, Intracerebral Hemorrhage, TIA (Transient Ischemic Attack), Stroke
Enrollment 1,000 participants
Start Date 2026-06-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22