Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-03 @ 2:42 PM
Study NCT ID:
NCT02316860
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2014-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Performance of Tilt Test in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2014-12-06', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test', 'timeFrame': '30 min', 'description': 'sensitivity = number of subjects with syncope/presyncope during tilt test/ number of subjects with a history of reflex syncope, specificity = number of subjects without syncope/presyncope during tilt test/ number of subjects without history of reflex syncope'}], 'secondaryOutcomes': [{'measure': 'Parameters of haemodynamics during tilt test', 'timeFrame': '30 min', 'description': 'We investigate whether the mean values of parameters of haemodynamics during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope'}, {'measure': 'Parameters of heart rate variability during tilt test', 'timeFrame': '30 min', 'description': 'We investigate whether the mean values of parameters of heart rate variability during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope'}, {'measure': 'Parameters of baroreflex sensitivity during tilt test', 'timeFrame': '30 min', 'description': 'We investigate whether the mean values of parameters of baroreflex sensitivity during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Syncope']}, 'descriptionModule': {'briefSummary': 'In the present study the investigators evaluate the sensitivity and specificity of passive tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for the improvement of diagnostic yield of tilt test in athletes.', 'detailedDescription': 'We examine athletes with a history of reflex syncope and athletes without history of reflex syncope.All subjects undergo a tilt test, for the evaluation of haemodynamics, heart rate variability (HRV) and baroreflex sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-40 years old,\n* more than 5 years of exercise training experience and competition at a regional level at different sports\n\nExclusion Criteria:\n\n* smoking,\n* recent alcohol consumption,\n* presence of any chronic disease and use of drugs'}, 'identificationModule': {'nctId': 'NCT02316860', 'briefTitle': 'The Diagnostic Performance of Tilt Test in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement', 'orgStudyIdInfo': {'id': 'sportscardiology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'History of reflex syncope', 'description': 'Passive tilt test in athletes with a history of reflex syncope', 'interventionNames': ['Other: Passive tilt test']}, {'type': 'OTHER', 'label': 'No history of reflex syncope', 'description': 'Passive tilt test in athletes without history of reflex syncope', 'interventionNames': ['Other: Passive tilt test']}], 'interventions': [{'name': 'Passive tilt test', 'type': 'OTHER', 'description': 'Passive tilt test (without pharmacological provocation). After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min. A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope', 'armGroupLabels': ['History of reflex syncope', 'No history of reflex syncope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54622', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Evangelia Kouidi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Sports Medicine-Cardiologist', 'investigatorFullName': 'Evangelia Kouidi', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}