- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07601659
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:
- cerebrovascular events (ischemic stroke, intracerebral hemorrhage, and transient ischemic attack [TIA]),
- 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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Giovanni Frisullo
- Numéro de téléphone: +393476612284
- E-mail: giovanni.frisullo@policlinicogemelli.it
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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.
La 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The rate of accuracy of Stroke Mimics Score (SMS)
Délai: through study completion, about 1 year
|
Diagnostic accuracy of the Stroke Mimics Score (SMS) in discriminating between:
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Analyses across clinical subgroups
Délai: 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.
|
through study completion, about 1 year
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Giovanni Frisullo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Hémorragie
- Ischémie cérébrale
- Hémorragies intracrâniennes
- Conditions pathologiques, signes et symptômes
- AVC ischémique
- Accident vasculaire cérébral
- Attaque ischémique, transitoire
- Hémorragie cérébrale
Autres numéros d'identification d'étude
- 27115
Informations sur les médicaments et les dispositifs, documents d'étude
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