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NCT Number: NCT07601659

Prospective Italian Validation of 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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:

    • 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.

Secondary outcomes

  1. Analyses across clinical subgroups

    Time frame: through study completion, about 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Frisullo

CONTACT

[email protected]

+393476612284

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Prospective Italian Multicenter Study for the Validation of the Stroke Mimics Score (SMS) in Patients With Suspected Acute Stroke

Acronym: PIVA-SMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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