NCT07601659Not yet recruiting
Prospective Italian Validation of SMS in Patients With Suspected Acute Stroke
Prospective Italian Multicenter Study for the Validation of the Stroke Mimics Score (SMS) in Patients With Suspected Acute Stroke
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 6 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Stroke
- NCT number
- NCT07601659
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jun 2026 to the primary completion date, 1 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to fully collect the data required to calculate the Stroke Mimics Score (SMS).
Age
- Age \< 18 years.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.