Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consc… (NCT06503653) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)
France52 participantsStarted 2024-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.