- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Giovanni Frisullo
- Telefonnummer: +393476612284
- E-post: giovanni.frisullo@policlinicogemelli.it
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
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.
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The rate of accuracy of Stroke Mimics Score (SMS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Analyses across clinical subgroups
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Giovanni Frisullo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Patologiska processer
- Blödning
- Hjärnischemi
- Intrakraniella blödningar
- Patologiska tillstånd, tecken och symtom
- Ischemisk stroke
- Stroke
- Ischemisk attack, övergående
- Hjärnblödning
Andra studie-ID-nummer
- 27115
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .