Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the … (NCT03528161) | Clinical Trial Compass
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Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term
France248 participantsStarted 2018-06-19
Plain-language summary
Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension. The etiological diagnosis is often uncertain and the prognostic assessment orients the outcome of the patient. The vast majority of syncope management costs are related to hospitalizations. Hospitalization in the immediate aftermath of emergency care is justified by a short-term prognosis. The current relevance of hospitalizations and the prognostic assessment of syncope is questioned.
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:
* Patients admitted to the emergency department for syncope as defined by European Society of Cardiology (ESC) recommendations.
Exclusion Criteria:
* Patient under guardianship or safeguard of justice
* Refusal to participate
* Inability to contact the patient again at M1, M3, M6
* Malaise without loss of consciousness (lipothymia)
* Loss of post-traumatic knowledge (after head trauma)
* Loss of consciousness of toxic origin
* Loss of consciousness of confirmed epileptic origin (known epileptic or strongly evocative history with post-critical state)
* Diagnosis performed during the initial emergency assessment of a major adverse cardiovascular event.
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.
What they're measuring
1
The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event
Timeframe: 30 days
2
The specificity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event