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Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study) (Sync'Hope)

V

Versailles Hospital

Status

Active, not recruiting

Conditions

Syncope

Treatments

Diagnostic Test: routine care
Diagnostic Test: syncope channel

Study type

Interventional

Funder types

Other

Identifiers

NCT06503653
P24/01_synchope

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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;
    • No structural heart disease or abnormal ECG.
  • Outpatient (returning home after emergency);

  • Beneficiary or beneficiary of a social security scheme (excluding AME).

Exclusion criteria

  • 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 design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Prospective part
Experimental group
Description:
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.
Treatment:
Diagnostic Test: syncope channel
Retrospective part:
Active Comparator group
Description:
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?
Treatment:
Diagnostic Test: routine care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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