About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Availability of a final hospital discharge diagnosis at the end of hospitalization or Emergency Department observation.
Disqualifiers
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.
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Locations
Sponsors and contacts
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