SyncopeF2NCT05752682
Global Approach to Faint and Falls
An observational study of Syncope and Fall, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- Diagnostic pathway
- How many people
- 340 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 31 Dec 2026
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: Patients with faint or fall referred to a Syncope Unit for diagnosis and therapy
Who may be able to join
- Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Auxologico Italiano
Milan, MI, 16149
Michele Brignole, 3204391422, mbrignole@outlook.it
Antonella Groppelli
About this study
Official title: Guideline-based Global Approach to the Management of Faints and Falls in a Dedicated Outpatient Facility
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.
Read more
Primary endpoint:
- Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls.
Secondary endpoints:
- Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis.
- Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations.
- Analysis of costs per patient of fall and syncope protocols
- All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years.
Inclusion criteria
- Consecutive patients >40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall.
- Fragile patients at risk of falling.
Exclusion criteria:
- Patients aged <40 years
- Patients with dental falls
- Patients with a known diagnosis of syncope
- Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities
Read the detailed description
- Background. 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.
- Aims of the study. To assess the effectiveness (adherence) of a patient flow pathway and cost of a guideline-based global approach to the management of faints and falls in patients referred to dedicated multidisciplinary outpatient facilities. We will considerer the following endpoints: Primary-endpoint:
- Point and interval prevalence estimation of patients with unexplained falls among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants. Secondary endpoints:
- Point and interval estimate of the agree proportion between initial presentation and final diagnosis in patients initially assigned to faint and those with unexplained falls. II. Descriptive comparison between patients initially assigned to faint and those with unexplained falls in terms of diagnostic assessment and adherence rate to the recommendations of the guidelines III. Descriptive cost analysis of the faint and fall protocol (costs of investigations per patient). Moreover, all previous analysis will be performed also for predefined age subgroups (≥75, 74-65 and 64-40 years).
- Study design Prospective observational study
Inclusion criteria
- Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall. The patients will be recruited from the second half of 2020 and the recruitment will continue until to the achievement of the sample size
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)
Patients' flow Each included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways (shown in the figure 1) developed in accordance with the most recent guidelines on syncope of the European Society of cardiology (1) and of guidelines on falls of the American and British Geriatrics Societies (2). The detailed flow pathway is described in the Appendix.
- Being tested
- Diagnostic pathway
- Keywords
- Syncope, Fall, Tilt table test, Ambulatory blood pressure monitoring, carotid sinus massage, implantable loop recorder, Treatment, Diagnosis
- Medical subject headings
- Syncope, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic pathwayDiagnostic test
Each included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways developed in accordance with the most recent guidelines on syncope of the European Society of cardiology and of guidelines on falls of the American and British Geriatrics Societies.
| Study group | Role | What they receive |
|---|---|---|
| Syncope and fall | Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall. Receives: Diagnostic Test: Diagnostic pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexplained falls
Point and interval prevalence estimation of patients with unexplained falls, among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants.
Measured: 1 year
Secondary outcomes (3)
Final diagnosis
Point and interval estimate of the agree proportion between initial presentation and final diagnosis in patients initially assigned to faint and those with unexplained falls.
Measured: 1 year
Comparison
Descriptive comparison between patients initially assigned to faint and those with unexplained falls in terms of diagnostic assessment and adherence rate to the recommendations of the guidelines
Measured: 1 year
Costs
Descriptive cost analysis of the faint and fall protocol (costs of investigations per patient).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Mar 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Brignole, Istituto Auxologico Italiano
- Investigators
- Michele Brignole, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752682
- Sponsor's protocol ID
- 09C021
- Acronym
- F2
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
PubMed 29562304Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.
PubMed 21226685
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline-based Global Approach to the Management of Faints and Falls in a Dedicated Outpatient Facility
- ClinicalTrials.gov ID
- NCT05752682
- Acronym / sponsor ID
- F2 / 09C021
- Keywords
- Syncope, Fall, Tilt table test, Ambulatory blood pressure monitoring, carotid sinus massage, implantable loop recorder, Treatment, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls.
Secondary endpoints:
- Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis.
- Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations.
- Analysis of costs per patient of fall and syncope protocols
- All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years.
Inclusion criteria
- Consecutive patients >40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall.
- Fragile patients at risk of falling.
Exclusion criteria:
- Patients aged <40 years
- Patients with dental falls
- Patients with a known diagnosis of syncope
- Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities
Detailed description
- Background. 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.
- Aims of the study. To assess the effectiveness (adherence) of a patient flow pathway and cost of a guideline-based global approach to the management of faints and falls in patients referred to dedicated multidisciplinary outpatient facilities. We will considerer the following endpoints: Primary-endpoint:
- Point and interval prevalence estimation of patients with unexplained falls among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants. Secondary endpoints:
- Point and interval estimate of the agree proportion between initial presentation and final diagnosis in patients initially assigned to faint and those with unexplained falls. II. Descriptive comparison between patients initially assigned to faint and those with unexplained falls in terms of diagnostic assessment and adherence rate to the recommendations of the guidelines III. Descriptive cost analysis of the faint and fall protocol (costs of investigations per patient). Moreover, all previous analysis will be performed also for predefined age subgroups (≥75, 74-65 and 64-40 years).
- Study design Prospective observational study
Inclusion criteria
- Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall. The patients will be recruited from the second half of 2020 and the recruitment will continue until to the achievement of the sample size
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)
Patients' flow Each included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways (shown in the figure 1) developed in accordance with the most recent guidelines on syncope of the European Society of cardiology (1) and of guidelines on falls of the American and British Geriatrics Societies (2). The detailed flow pathway is described in the Appendix.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syncope and fall | – | Diagnostic Test: Diagnostic pathwayConsecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with faint or fall referred to a Syncope Unit for diagnosis and therapy
Key inclusion criteria (1 listed)
- Consecutive patients aged ≥40 years referred to the Faint \& Fall Clinics for assessment of an episode of faint or fall.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic pathwayEach included patient will undergo to the faint and fall protocol, to assess the effectiveness of a patients' flow pathways developed in accordance with the most recent guidelines on syncope of the European Society of cardiology and of guidelines on falls of the American and British Geriatrics Societies. | Diagnostic test | Syncope and fall |
Primary outcome
Unexplained falls
Time frame: 1 year
Point and interval prevalence estimation of patients with unexplained falls, among those who underwent fall diagnostic assessment at initial presentation and then moved to faint pathway for prosecution of diagnostic assessment and its determinants.
3 secondary outcomes
Final diagnosis
Time frame: 1 year
Comparison
Time frame: 1 year
Costs
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 29562304Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
- Background: PubMed 21226685Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michele Brignole principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Fall, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Brignole (+393204391422, mbrignole@outlook.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexplained falls (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752682, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.