Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-09 @ 4:39 AM
Study NCT ID:
NCT03528161
Status:
UNKNOWN
Last Update Posted:
2018-07-09
First Post:
2018-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-05', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event', 'timeFrame': '30 days', 'description': '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.\n\nThe 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.'}, {'measure': 'The specificity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event', 'timeFrame': '30 days', 'description': '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.\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'The positive and negative predictive values of hypersensitive troponin', 'timeFrame': '6 months', 'description': 'The positive and negative predictive values of hypersensitive troponin in the prediction of short-term serious events'}, {'measure': 'The hypersensitive troponin performance', 'timeFrame': '6 months', 'description': 'The hypersensitive troponin performance (sensitivity) in the prediction of the occurrence of a major adverse cardiovascular event at 3 and 6 months after syncope'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypersensitive troponin', 'risk of serious adverse events', 'emergency'], 'conditions': ['Syncope']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\n248 patients admitted for syncope.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the emergency department for syncope as defined by European Society of Cardiology (ESC) recommendations.\n\nExclusion Criteria:\n\n* Patient under guardianship or safeguard of justice\n* Refusal to participate\n* Inability to contact the patient again at M1, M3, M6\n* Malaise without loss of consciousness (lipothymia)\n* Loss of post-traumatic knowledge (after head trauma)\n* Loss of consciousness of toxic origin\n* Loss of consciousness of confirmed epileptic origin (known epileptic or strongly evocative history with post-critical state)\n* Diagnosis performed during the initial emergency assessment of a major adverse cardiovascular event.'}, 'identificationModule': {'nctId': 'NCT03528161', 'acronym': 'TROPOCOPE', 'briefTitle': 'Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term', 'orgStudyIdInfo': {'id': 'RC31/18/0118'}, 'secondaryIdInfos': [{'id': '2018-A01278-47', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Measurement of hypersensitive troponin', 'type': 'OTHER', 'description': 'Telephone follow-up at one month, 3 months and 6 months by a clinical research technician. Collection of serious adverse events, reports of hospitalization.\n\nThe 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric Balen, MD', 'role': 'CONTACT', 'email': 'balen.f@chu-toulouse.fr', 'phone': '05 61 32 27 93', 'phoneExt': '33'}, {'name': 'Isabelle Olivier, PhD', 'role': 'CONTACT', 'email': 'olivier.i@chu-toulouse.fr', 'phone': '05 61 77 70 51', 'phoneExt': '33'}], 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Frédéric Balen, MD', 'role': 'CONTACT', 'email': 'balen.f@chu-toulouse.fr', 'phone': '05 61 32 27 93', 'phoneExt': '33'}, {'name': 'Isabelle Olivier, PhD', 'role': 'CONTACT', 'email': 'olivier.i@chu-toulouse.fr', 'phone': '05 61 77 70 51', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Frédéric Balen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}