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

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ClinicalTrials.gov Identifier: NCT03528161
Recruitment Status : Unknown
Verified July 2018 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : May 17, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment
Syncope 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.

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Study Type : Observational
Estimated Enrollment : 248 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Fainting


Intervention Details:
  • 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.



Primary Outcome Measures :
  1. The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event [ Time Frame: 30 days ]

    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.


  2. The specificity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event [ Time Frame: 30 days ]

    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.



Secondary Outcome Measures :
  1. The positive and negative predictive values of hypersensitive troponin [ Time Frame: 6 months ]
    The positive and negative predictive values of hypersensitive troponin in the prediction of short-term serious events

  2. The hypersensitive troponin performance [ Time Frame: 6 months ]
    The hypersensitive troponin performance (sensitivity) in the prediction of the occurrence of a major adverse cardiovascular event at 3 and 6 months after syncope



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528161


Contacts
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Contact: Frédéric Balen, MD 05 61 32 27 93 ext 33 balen.f@chu-toulouse.fr
Contact: Isabelle Olivier, PhD 05 61 77 70 51 ext 33 olivier.i@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Frédéric Balen, MD    05 61 32 27 93 ext 33    balen.f@chu-toulouse.fr   
Contact: Isabelle Olivier, PhD    05 61 77 70 51 ext 33    olivier.i@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Frédéric Balen, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03528161    
Other Study ID Numbers: RC31/18/0118
2018-A01278-47 ( Other Identifier: ID-RCB )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
hypersensitive troponin
risk of serious adverse events
emergency
Additional relevant MeSH terms:
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Syncope
Hypersensitivity
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Immune System Diseases