| NCT ID | NCT05752682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Syncope |
| Study Type | OBSERVATIONAL |
| Enrollment | 340 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 340 participants in total. It began in 2020-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Syncope is the most frequent cause of transient loss of consciousness. Falls are very common in older people. If the falls are unexplained and not accidental, it is likely that the patient had a syncope event and showed a lack of awareness for loss of consciousness. The management of unexplained falls is the same as that of syncope. There is a gap between the best available scientific evidence provided by the guidelines and the need to disseminate these concepts in clinical practice. The absence of a systematic comprehensive approach to fainting and falls results in higher health and social costs, unnecessary hospitalizations and diagnostic procedures, prolonged hospital stays, lower diagnostic rates, and higher rates of misdiagnosis and symptomatic recurrence. Aim of the study The aim of the study is to assess the efficacy (adherence) of a diagnostic protocol and the costs of a comprehensive guideline-based approach to the management of fainting and falls in a population of consecutive patients referred to a dedicated multidisciplinary outpatient facility. Primary endpoint: 1\. Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls. Secondary endpoints: 1. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis. 2. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations. 3. Analysis of costs per patient of fall and syncope protocols 4. All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years. Inclusion criteria 1. Consecutive patients \>40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall. 2. Fragile patients at risk of falling. Exclusion criteria: 1. Patients aged \<40 years 2. Patients with dental falls 3. Patients with a known diagnosis of syncope 4. Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities
Eligibility Criteria
Inclusion Criteria: * Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall. Exclusion Criteria: * Patients with age \<40 years * Patients with incidental fall * Patients with an established diagnosis of syncope * Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities (e.g: acute myocardial infarction, pulmonary embolism, acute haemorrage)
Contact & Investigator
Michele Brignole
PRINCIPAL INVESTIGATOR
Istituto Auxologico Italiano
Frequently Asked Questions
Who can join the NCT05752682 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Syncope. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05752682 currently recruiting?
Yes, NCT05752682 is actively recruiting participants. Contact the research team at mbrignole@outlook.it for enrollment information.
Where is the NCT05752682 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05752682 clinical trial?
NCT05752682 is sponsored by Istituto Auxologico Italiano. The principal investigator is Michele Brignole at Istituto Auxologico Italiano. The trial plans to enroll 340 participants.