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NCT Number: NCT06503653

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

centre hospitalier de Versailles

Le Chesnay, Yvelines, 78390, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

syncope channel

Diagnostic 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 care

Diagnostic 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

Primary outcomes

  1. etiological diagnosis of synchope

    Time frame: 3 months

    Percentage of patients for whom at least one etiological diagnosis of syncope was identified.

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Acronym: Sync'Hope

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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