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

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.

Study Overview

• Status: Unknown
• Conditions: Syncope
• Intervention / Treatment: Other: Measurement of hypersensitive troponin

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.

• Study Type: Observational
• Enrollment (Anticipated): 248

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse
    • Contact: Frédéric Balen, MD; Phone Number: 33 05 61 32 27 93; Email: balen.f@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The positive and negative predictive values of hypersensitive troponin	The positive and negative predictive values of hypersensitive troponin in the prediction of short-term serious events	6 months
The hypersensitive troponin performance	The hypersensitive troponin performance (sensitivity) in the prediction of the occurrence of a major adverse cardiovascular event at 3 and 6 months after syncope	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Frédéric Balen, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: emergency; hypersensitive troponin; risk of serious adverse events
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Hypersensitivity; Syncope
• Other Study ID Numbers: RC31/18/0118; 2018-A01278-47 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No