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)

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 Overview

• Status: Active, not recruiting
• Conditions: Syncope
• Intervention / Treatment: Diagnostic test: syncope channel; Diagnostic test: routine care

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Yvelines
    • Le Chesnay, Yvelines, France, 78390
      • Centre Hospitalier De Versailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective part; 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.	Diagnostic test: syncope channel; 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.
Active Comparator: Retrospective part: 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?	Diagnostic test: routine care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
etiological diagnosis of synchope	Percentage of patients for whom at least one etiological diagnosis of syncope was identified.	3 months

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Syncope
• Other Study ID Numbers: P24/01_synchope

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No