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Recruiting Observational

Predictors of Emergency Department Use in Frail Patients

NCT07259499 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-11-19
Last updated
2025-12-02

Condition(s) studied

Alzheimer s DiseaseVascular DementiaFrailtyElderlyEmergency Department VisitsAutonomy

Investigational drug(s) / intervention(s)

Plasma phosphorylated Tau 181

Plasma phosphorylated Tau 181: Plasma will be collected in dipotassium EDTA tubes at recruitment and centrifugated at 1800-2000xg for 10 minutes within a short data frame. Plasma will be subsequently aliquoted and stored at -80°C. Immediately prior to analysis, samples will be thawed at room temperature, vortexed, and centrifuged. Plasma p-tau181 concentrations will be then quantified using a fully automated chemiluminescent enzyme immunoassay on the LUMIPULSE G600II system, in accordance with the manufacturer's instructions.

Study summary

When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * fluency in Italian language, * age higher than 64 years, * loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires, * having performed routinary blood exams in the 6 months prior to recruitment * having performed head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment. Exclusion Criteria: * withdrawal of the informed consent

Primary outcome measure(s)

  • Emergency Department Use — Within 6 months from recruitment
    The patient visits an emergency department (ED). The proportion of participants visiting the ED will be assessed at the end of the observational period. Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedaliera Universitaria Pisana Pisa Pisa Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07259499 on ClinicalTrials.gov ↗ ← All trials in Italy