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

NCT03528161 | Unknown

• 2 other identifiers: RC31/18/01182018-A01278-47
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope

Keywords

hypersensitive troponin; risk of serious adverse events; emergency

Outcome Measures

Primary Outcomes (2)

• The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event

  The sensitivity of hypersensitive troponin in predicting the occurrence within 30 days of a major undesirable cardiovascular adverse event Positive and negative likelihood ratios (defined from sensitivity and specificity) will also be estimated. The definition of a major cardiovascular adverse event was chosen based on recommendations published in the Academy of Emergency Medicine (38) and the American College of Emergency Medicine The primary endpoint will be evaluated in all patients within 30 days of the troponin assay, blinded to the outcome of the biological variable.

  30 days

• The specificity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event

  The specificity of hypersensitive troponin in predicting the occurrence within 30 days of a major undesirable cardiovascular adverse event Positive and negative likelihood ratios (defined from sensitivity and specificity) will also be estimated. The definition of a major cardiovascular adverse event was chosen based on recommendations published in the Academy of Emergency Medicine (38) and the American College of Emergency Medicine The primary endpoint will be evaluated in all patients within 30 days of the troponin assay, blinded to the outcome of the biological variable.

  30 days

Secondary Outcomes (2)

• The positive and negative predictive values of hypersensitive troponin

  6 months

• The hypersensitive troponin performance

  6 months

Interventions

Measurement of hypersensitive troponin OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Knowing that the number of malaise admitted per year to emergencies is 3972 (2016 data), and 20% are syncope (about 800 syncope per year), recruitment can be done in 12 months. 248 patients admitted for syncope.

You may qualify if:

• Patients admitted to the emergency department for syncope as defined by European Society of Cardiology (ESC) recommendations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Syncope; Emergencies

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Frédéric Balen, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Balen, MD

CONTACT

05 61 32 27 93; balen.f@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 17, 2018
• Study Start: June 19, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 9, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)