NCT03528161

Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 248 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The improvement of cardiac troponin assay techniques has increased its sensitivity to detect myocardial ischemic conditions, even at the expense of a loss of specificity. Myocardial infarction type 2 is due to an imbalance between needs and oxygen supply to cardiomyocytes at the time of an increase of the first and / or a decrease of the second and is favored by an underlying cardiovascular field fragile. Syncope, because of the low flow that they imply, can be the cause of a type II myocardial infarction on fragile cardiovascular ground. The study is prospectively conducted in all patients admitted for syncope to assess the actual diagnostic performance of hypersensitive troponin in the syncope risk stratification. The primary benefit is to identify patients at risk of serious cardiac events in the short term. The secondary benefits expected from the study are a decrease in unjustified hospitalizations of patients admitted to the emergency for syncope and thus a decrease in the cost of care. The validation of the indication of the troponin assay in the stratification of the risk after a syncope passes by its prospective evaluation in a prognostic study.

Conditions

• Syncope

Interventions

Type	Name	Description
OTHER	Measurement of hypersensitive troponin	Telephone follow-up at one month, 3 months and 6 months by a clinical research technician. Collection of serious adverse events, reports of hospitalization. The hypersensitive troponin assay will be recently proposed in a short-term risk stratification score after syncope (30 days), the canadian syncope risk score. If hypersensitive troponin benefits from interesting performances it needs to be evaluated prospectively, as measured only in 47.9% of syncope in this study. Hypersensitive troponin could be a prognostic marker of early serious adverse cardiovascular events in syncope.

Timeline

• Start date: 2018-06-19
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-05-17
• Last updated: 2018-07-09

Locations

1 site across 1 country: France