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

NCT ID: NCT03528161

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Balen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frédéric Balen, MD

Role: CONTACT

balen.f@chu-toulouse.fr

05 61 32 27 93 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Facility Contacts

Frédéric Balen, MD

Role: primary

balen.f@chu-toulouse.fr

05 61 32 27 93 ext. 33

Isabelle Olivier, PhD

Role: backup

olivier.i@chu-toulouse.fr

05 61 77 70 51 ext. 33

Other Identifiers

2018-A01278-47

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0118

Identifier Type: -

Identifier Source: org_study_id