Syncope2STEPSNCT05728255
Assessment of the Mechanism of Non-cardiac Syncope
An observational study of Syncope and Syncope, Vasovagal, run by Istituto Auxologico Italiano at 8 sites in 5 countries.
Trial summary
Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Syncope, Vasovagal, Orthostatic Hypotension
- What is being tested?
- ABPM plys SCAFB
- How many people
- 330 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Apr 2024to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe syncopes are those patients who are asking for mechanism-specific therapy because they are affected by recurrent syncopes impairing quality of life or have syncopes with absent or very short prodrome increasing the risk of injuries or are at risk of syncope during high-risk activities (e.g., driving, machine operation, flying, or competitive athletics, etc.).
Who may be able to join
- severe recurrent non-cardiac syncope referred for assessment of the mechanism of syncope. Non-cardiac syncope is diagnosed when the clinical features are consistent with reflex syncope and orthostatic hypotension, and cardiac syncope is ruled out .
Who cannot join
- Non-syncopal causes of real or apparent loss of consciousness that may be incorrectly diagnosed as syncope (eg, unexplained falls, epilepsy, psychogenic pseudosyncope and other rare causes)
- Established or suspected cardiac syncope in complying with the criteria of the European Society of Cardiology (ESC) syncope guidelines (1). Specifically, these were the patients with: (i) suspected cardiac arrhythmic syncope [inadequate sinus bradycardia (<50 b.p.m.) or sinoatrial block, second-degree Mobitz I atrioventricular block, second-degree Mobitz II or third-degree atrioventricular block, paroxysmal tachyarrhythmia or ventricular tachycardia, bundle branch block]; (ii) severe structural heart disease and/or significant ECG abnormalities, as defined in Table 2 of those guidelines (1).
- Classical orthostatic hypotension diagnosed at the initial evaluation by Active Standing test
- Constitutional or drug-induced persistent hypotension already diagnosed at the initial evaluation by office BP measurement or previous historical features
- Non-severe forms of non-cardiac syncope, i.e., patients with rare and mild episodes occurring in low-risk situations. In these patients the investigation of the underlying mechanism of syncope is not necessary and treatment strategies are mainly based on education on preventive measures, lifestyle modification, and reassurance regarding the benign nature of the condition.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Italy4 sites
University of Florence
Florence
ospdali del Tigullio
Lavagna
IRCCS Istituto Auxologico Italiano
Milan, MI, 16149
Università della Campania Vamvitelli
Naples
About this study
Official title: Assessment of the Mechanism of Non-cardiac Syncope by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) and Tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB)
Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy.
Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table
Read the detailed description
Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Indeed, the choice of appropriate therapy and its efficacy are largely determined by the mechanism of syncope rather than its aetiology or clinical presentation. The identified mechanism of syncope should be carefully assessed and assigned either to hypotensive or bradycardic phenotype, which will determine the choice of therapy (counteracting hypotension or counteracting bradycardia).
Several tests have been developed to identify the mechanism of non-cardiac syncope. The great number of tests, most of them being time-consuming, is one of the barriers for widespread utilization in the busy clinical practice. They are expensive and often not fully reimbursed by the health services.
Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB). SCAFB consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table
The study hypothesis is that these two investigations, performed in sequence, can identify the mechanism of syncope in most of the patients in a quick and easy-to-perform way and at relatively low costs.
- Being tested
- ABPM plys SCAFB
- Keywords
- Syncope, Orthostatic hypotension, Tilt table test, Ambulatory blood pressure monitoring
- Medical subject headings
- Syncope, Syncope, Vasovagal, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABPM plys SCAFBDiagnostic test
24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM) and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Prevalence of hypotensive and bradycardic phenotypes
Measured: 1 month
Secondary outcomes (2)
Diagnostic yield
Diagnostic yield of ABPM and of SCAFB
Measured: 1 month
Diagnosis
Case mix of etiologic diagnoses
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Apr 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728255
- Sponsor's protocol ID
- 09C337
- Acronym
- 2STEPS
- Status last verified
- Jul 2024
- First submitted
- 4 Feb 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rivasi G, Groppelli A, Brignole M, Soranna D, Zambon A, Bilo G, Pengo M, Sharad B, Hamrefors V, Rafanelli M, Testa GD, Rice C, Kenny RA, Sutton R, Ungar A, Fedorowski A, Parati G. Association between hypotension during 24 h ambulatory blood pressure monitoring and reflex syncope: the SynABPM 1 study. Eur Heart J. 2022 Oct 11;43(38):3765-3776. doi: 10.1093/eurheartj/ehac347.
PubMed 35766175Brignole M, Rivasi G. New insights in diagnostics and therapies in syncope: a novel approach to non-cardiac syncope. Heart. 2021 Jun;107(11):864-873. doi: 10.1136/heartjnl-2020-318261. Epub 2021 Jan 18.
PubMed 33462120
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Mechanism of Non-cardiac Syncope by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) and Tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB)
- ClinicalTrials.gov ID
- NCT05728255
- Acronym / sponsor ID
- 2STEPS / 09C337
- Keywords
- Syncope, Orthostatic hypotension, Tilt table test, Ambulatory blood pressure monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 15 Feb 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.
Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy.
Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table
Detailed description
Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Indeed, the choice of appropriate therapy and its efficacy are largely determined by the mechanism of syncope rather than its aetiology or clinical presentation. The identified mechanism of syncope should be carefully assessed and assigned either to hypotensive or bradycardic phenotype, which will determine the choice of therapy (counteracting hypotension or counteracting bradycardia).
Several tests have been developed to identify the mechanism of non-cardiac syncope. The great number of tests, most of them being time-consuming, is one of the barriers for widespread utilization in the busy clinical practice. They are expensive and often not fully reimbursed by the health services.
Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB). SCAFB consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table
The study hypothesis is that these two investigations, performed in sequence, can identify the mechanism of syncope in most of the patients in a quick and easy-to-perform way and at relatively low costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe syncopes are those patients who are asking for mechanism-specific therapy because they are affected by recurrent syncopes impairing quality of life or have syncopes with absent or very short prodrome increasing the risk of injuries or are at risk of syncope during high-risk activities (e.g., driving, machine operation, flying, or competitive athletics, etc.).
Key inclusion criteria (1 listed)
- severe recurrent non-cardiac syncope referred for assessment of the mechanism of syncope. Non-cardiac syncope is diagnosed when the clinical features are consistent with reflex syncope and orthostatic hypotension, and cardiac syncope is ruled out .
Key exclusion criteria (5 listed)
- Non-syncopal causes of real or apparent loss of consciousness that may be incorrectly diagnosed as syncope (eg, unexplained falls, epilepsy, psychogenic pseudosyncope and other rare causes)
- Established or suspected cardiac syncope in complying with the criteria of the European Society of Cardiology (ESC) syncope guidelines (1). Specifically, these were the patients with: (i) suspected cardiac arrhythmic syncope [inadequate sinus bradycardia (<50 b.p.m.) or sinoatrial block, second-degree Mobitz I atrioventricular block, second-degree Mobitz II or third-degree atrioventricular block, paroxysmal tachyarrhythmia or ventricular tachycardia, bundle branch block]; (ii) severe structural heart disease and/or significant ECG abnormalities, as defined in Table 2 of those guidelines (1).
- Classical orthostatic hypotension diagnosed at the initial evaluation by Active Standing test
- Constitutional or drug-induced persistent hypotension already diagnosed at the initial evaluation by office BP measurement or previous historical features
- Non-severe forms of non-cardiac syncope, i.e., patients with rare and mild episodes occurring in low-risk situations. In these patients the investigation of the underlying mechanism of syncope is not necessary and treatment strategies are mainly based on education on preventive measures, lifestyle modification, and reassurance regarding the benign nature of the condition.
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 |
|---|---|---|
| ABPM plys SCAFB24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM) and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table | Diagnostic test | – |
Primary outcome
Prevalence
Time frame: 1 month
Prevalence of hypotensive and bradycardic phenotypes
2 secondary outcomes
Diagnostic yield
Time frame: 1 month
Diagnosis
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 35766175Rivasi G, Groppelli A, Brignole M, Soranna D, Zambon A, Bilo G, Pengo M, Sharad B, Hamrefors V, Rafanelli M, Testa GD, Rice C, Kenny RA, Sutton R, Ungar A, Fedorowski A, Parati G. Association between hypotension during 24 h ambulatory blood pressure monitoring and reflex syncope: the SynABPM 1 study. Eur Heart J. 2022 Oct 11;43(38):3765-3776. doi: 10.1093/eurheartj/ehac347.
- Results publication: PubMed 33462120Brignole M, Rivasi G. New insights in diagnostics and therapies in syncope: a novel approach to non-cardiac syncope. Heart. 2021 Jun;107(11):864-873. doi: 10.1136/heartjnl-2020-318261. Epub 2021 Jan 18.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Syncope, Vasovagal, run by Istituto Auxologico Italiano at 8 sites in 5 countries.
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 5 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: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, France, Netherlands, Spain, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: 1 month). 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 NCT05728255, 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 17 Jul 2024.