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

T

Toulouse University Hospital

Status

Unknown

Conditions

Syncope

Treatments

Other: Measurement of hypersensitive troponin

Study type

Observational

Funder types

Other

Identifiers

NCT03528161
RC31/18/0118
2018-A01278-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

248 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Frédéric Balen, MD; Isabelle Olivier, PhD

Data sourced from clinicaltrials.gov

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