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

Not Applicable

Active, not recruiting

• Conditions: Syncope
• Interventions: Diagnostic Test: routine care; Diagnostic Test: syncope channel

• Registration Number: NCT06503653
• Lead Sponsor: Versailles Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-31
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Retrospective part:	routine care	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?
Prospective part	syncope channel	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.

Primary Outcome Measures

Name	Time	Method
etiological diagnosis of synchope	3 months	Percentage of patients for whom at least one etiological diagnosis of syncope was identified.

Trial Locations

Locations (1)

centre hospitalier de Versailles; 🇫🇷 Le Chesnay, Yvelines, France