SyncopeSync'HopeNCT06503653
Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)
A study testing syncope channel and routine care in people with Syncope, run by Versailles Hospital at 1 site in France.
Trial summary
The main aim of this study is to assess the value of creating a "syncope pathway" to optimize diagnostic performance in patients admitted to the emergency department for syncope and not hospitalized, compared with the previous pre-syncope pathway situation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- syncope channel and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2024to 27 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Adults aged 18 and over;
- Consultant at the emergency department of the Centre Hospitalier de V ersailles
- For a confirmed diagnosis:
- of recurrent syncope with low-risk criteria according to ESC 2018 (1,2) Or
- of syncope recurrent or not, not fulfilling low-risk or high-risk criteria according to the ESC 2018 definition (1,2). These patients are those with minor high-risk criteria without aggravating circumstances:
- With no personal history of loss of consciousness whose clinical features strongly suggest syncope of rhythmic origin;
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- No structural heart disease or abnormal ECG.
- Outpatient (returning home after emergency);
- Beneficiary or beneficiary of a social security scheme (excluding AME).
Who cannot join
- Etiology of syncope identified as early as the emergency department visit;
- High-risk syncope according to ESC 2018 criteria (1,3);
- First and only episode of low-risk syncope according to ESC 2018 criteria (1,3);
- Syncope of any risk category requiring hospitalization at the discretion of the emergency physician and cardiologist;
- Legal protection by guardianship ;
- Language barrier or condition incompatible with the patient's understanding or informed adherence to the protocol;
- Opposition to the use of their pseudonymized data (for retrospective inclusions);
- Patient's refusal to give consent to participate in the study (for prospective inclusions);
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this study is to assess the value of creating a "syncope pathway" to optimize diagnostic performance in patients admitted to the emergency department for syncope and not hospitalized, compared with the previous pre-syncope pathway situation.
- Conditions
- Syncope
- Being tested
- syncope channel, routine care
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
syncope channelDiagnostic test
The procedures and investigations proposed for the etiological diagnosis of low-risk or "neither high nor low" syncope and included in the study are those recommended by the European Society of Cardiology.
No additional procedures, invasive or non-invasive explorations or blood sampling not provided for as part of routine care will be offered or carried out as part of the study.
The only change in practice for patients included in the "syncope pathway The only change in practice concerns the grouping of patients included in the "syncope pathway" into a single day at a day hospital within 10 days of their emergency consultation.
routine careDiagnostic test
The procedures and investigations proposed for the etiological diagnosis of low-risk or "neither high nor low" syncope and included in the study are those recommended by the European Society of Cardiology.in routine care, medical examinations are carried out by specialists such as cardiologists who do not practice in hospitals
| Study group | Role | What they receive |
|---|---|---|
| Prospective part | Experimental | Prospective part: Patients admitted for syncope in the emergency department, diagnosed with syncope and not hospitalized.
Summoned within 7 to 10 days to a cardiology day hospital for examinations adapted to each patient: ECG - ETT - Holter ECG 72h - orthostatic hypotension test - post-emergency cardiology consultation - MAPA and +/- other examinations as required. Receives: Diagnostic Test: syncope channel |
| Retrospective part: | Active comparator | Retrospective part: Patients with syncope discharged home from the emergency department, before the creation of the network:
* Information sent to patients and record of patient's non-opposition;
* Patients are called back by telephone or, failing that, by a trusted support person or attending physician;
* What happens to these patients? Have they seen a cardiologist within 10 days? What additional examinations did they have in town? Recurrence? Did they return to the emergency department for the same reason? Receives: Diagnostic Test: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
etiological diagnosis of synchope
Percentage of patients for whom at least one etiological diagnosis of syncope was identified.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start31 Mar 2024
- Primary completion20 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr laura Eouzan dahan, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503653
- Sponsor's protocol ID
- P24/01_synchope
- Acronym
- Sync'Hope
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)
- ClinicalTrials.gov ID
- NCT06503653
- Acronym / sponsor ID
- Sync'Hope / P24/01_synchope
- Conditions
- Syncope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 16 Jul 2024 (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.
The main aim of this study is to assess the value of creating a "syncope pathway" to optimize diagnostic performance in patients admitted to the emergency department for syncope and not hospitalized, compared with the previous pre-syncope pathway situation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective part | Experimental | Diagnostic Test: syncope channelProspective part: Patients admitted for syncope in the emergency department, diagnosed with syncope and not hospitalized. Summoned within 7 to 10 days to a cardiology day hospital for examinations adapted to each patient: ECG - ETT - Holter ECG 72h - orthostatic hypotension test - post-emergency cardiology consultation - MAPA and +/- other examinations as required. |
| Retrospective part: | Active comparator | Diagnostic Test: routine careRetrospective part: Patients with syncope discharged home from the emergency department, before the creation of the network: * Information sent to patients and record of patient's non-opposition; * Patients are called back by telephone or, failing that, by a trusted support person or attending physician; * What happens to these patients? Have they seen a cardiologist within 10 days? What additional examinations did they have in town? Recurrence? Did they return to the emergency department for the same reason? |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 and over;
- Consultant at the emergency department of the Centre Hospitalier de V ersailles
- For a confirmed diagnosis:
- of recurrent syncope with low-risk criteria according to ESC 2018 (1,2) Or
- of syncope recurrent or not, not fulfilling low-risk or high-risk criteria according to the ESC 2018 definition (1,2). These patients are those with minor high-risk criteria without aggravating circumstances:
Key exclusion criteria (8 listed)
- Etiology of syncope identified as early as the emergency department visit;
- High-risk syncope according to ESC 2018 criteria (1,3);
- First and only episode of low-risk syncope according to ESC 2018 criteria (1,3);
- Syncope of any risk category requiring hospitalization at the discretion of the emergency physician and cardiologist;
- Legal protection by guardianship ;
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 |
|---|---|---|
| syncope channelThe procedures and investigations proposed for the etiological diagnosis of low-risk or "neither high nor low" syncope and included in the study are those recommended by the European Society of Cardiology. No additional procedures, invasive or non-invasive explorations or blood sampling not provided for as part of routine care will be offered or carried out as part of the study. The only change in practice for patients included in the "syncope pathway The only change in practice concerns the grouping of patients included in the "syncope pathway" into a single day at a day hospital within 10 days of their emergency consultation. | Diagnostic test | Prospective part |
| routine careThe procedures and investigations proposed for the etiological diagnosis of low-risk or "neither high nor low" syncope and included in the study are those recommended by the European Society of Cardiology.in routine care, medical examinations are carried out by specialists such as cardiologists who do not practice in hospitals | Diagnostic test | Retrospective part: |
Primary outcome
etiological diagnosis of synchope
Time frame: 3 months
Percentage of patients for whom at least one etiological diagnosis of syncope was identified.
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 23 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing syncope channel and routine care in people with Syncope, run by Versailles Hospital at 1 site in France.
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 9 inclusion and 8 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 23 Oct 2026. 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 France. 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?
etiological diagnosis of synchope (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.