Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02140567
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2014-04-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Syncope Prediction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019462', 'term': 'Syncope, Vasovagal'}], 'ancestors': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'p.b.lim@imperial.ac.uk', 'phone': '+44', 'title': 'Dr. Phang Boon Lim', 'phoneExt': '(0)20 3313', 'organization': 'Imperial College Healthcare NHS Trust in London, United Kingdom'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 hour', 'eventGroups': [{'id': 'EG000', 'title': 'Syncope Prediction', 'description': 'Enrolled participants who performed the tilt test', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 0, 'seriousNumAtRisk': 140, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of the Syncope Prediction Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Syncope Prediction (Sensitivity)', 'description': 'Tilt-positive participants included in the efficacy analysis'}], 'classes': [{'categories': [{'title': 'True positive', 'measurements': [{'value': '81', 'groupId': 'OG000'}]}, {'title': 'False negative', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Tilt Test with average duration of 1 hour', 'description': 'Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with positive tilt-test'}, {'type': 'PRIMARY', 'title': 'Specificity of the Syncope Prediction Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Syncope Prediction (Specificity)', 'description': 'Tilt-negative participants included in the efficacy analysis'}], 'classes': [{'categories': [{'title': 'True negative', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'False positive', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Tilt Test with average duration of 1 hour', 'description': 'Number of tilt-negative participants identified as negative by the syncope prediction algorithm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with negative tilt-test'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Syncope Prediction Study', 'description': 'All enrolled participants who performed a tilt test.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Problems with recording equipment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Syncope Prediction', 'description': 'Enrolled participants who performed tilt test and were included in efficacy analysis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '15.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants included in efficacy analysis'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2014-04-30', 'resultsFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2014-05-14', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-01', 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the Syncope Prediction Algorithm', 'timeFrame': 'Tilt Test with average duration of 1 hour', 'description': 'Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm'}, {'measure': 'Specificity of the Syncope Prediction Algorithm', 'timeFrame': 'Tilt Test with average duration of 1 hour', 'description': 'Number of tilt-negative participants identified as negative by the syncope prediction algorithm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vasovagal Syncope']}, 'referencesModule': {'references': [{'pmid': '29715516', 'type': 'DERIVED', 'citation': 'Virag N, Erickson M, Taraborrelli P, Vetter R, Lim PB, Sutton R. Predicting vasovagal syncope from heart rate and blood pressure: A prospective study in 140 subjects. Heart Rhythm. 2018 Sep;15(9):1404-1410. doi: 10.1016/j.hrthm.2018.04.032. Epub 2018 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.', 'detailedDescription': 'Vasovagal syncope (VVS) is a form of neurally-mediated reflex syncope, which is marked by a sudden fall in blood pressure with an associated fall in heart rate often resulting in syncope, head-up tilt (HUT) testing is commonly used to bring information about VVS using ECG and blood pressure monitoring with medical observation.\n\nWe developed an algorithm, called Tilt Test Analyzer, to predict VVS during HUT based on the simultaneous analysis of heart rate (RR interval), systolic blood pressure (SBP) and an indicator of autonomic modulation represented by heart rate and blood pressure variability (HRV and BPV).\n\nThe primary objective of this study is to evaluate the VVS prediction algorithm in a prospective cohort of patients in the tilt laboratory The primary endpoint is the VVS prediction algorithm performance by means of measuring the sensitivity and specificity values.\n\nThe study is designed to test if the prospective analysis of tilt-test patients can reproduce the results previously obtained in the published retrospective analysis on 1155 patients with a similar clinically relevant sensitivity and specificity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Vasovagal syncope patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the center with vasovagal syncope for tilt testing.\n* The patient is willing and able to cooperate with the study procedures.\n* The subject or legal guardian is able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years or over 90 years old.\n* Women who are currently pregnant or have a positive pregnancy test.\n* Patients who had a prior tilt test.\n* Patients enrolled in another device or drug study.'}, 'identificationModule': {'nctId': 'NCT02140567', 'acronym': 'SPS', 'briefTitle': 'Syncope Prediction Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic BRC'}, 'officialTitle': 'Syncope Prediction Study', 'orgStudyIdInfo': {'id': 'Syncope Prediction Study'}, 'secondaryIdInfos': [{'id': 'SPS', 'type': 'OTHER', 'domain': 'sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Syncope Prediction', 'description': 'All enrolled patients that performed the tilt table test'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'P Boon Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic BRC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}