Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 2:39 PM
Study NCT ID:
NCT03721393
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Collection - Of Syncope Tilt Table Testing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007024', 'term': 'Hypotension, Orthostatic'}, {'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': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiologic Signal Detection', 'timeFrame': '12 months', 'description': 'Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tilt table test, valsalva'], 'conditions': ['Orthostatic Hypotension', 'Reflex Syncope']}, 'descriptionModule': {'briefSummary': 'To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.\n\nTo evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.', 'detailedDescription': 'This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.\n\nA maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have previously undergone a ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and capable to provide informed consent\n* Age 18 or above\n* No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)\n* Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.\n* Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)\n\nExclusion Criteria:\n\n* Currently enrolled in another clinical trial that might interfere with data collection.\n* Subject is pregnant or planning to become pregnant during the study\n* Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.\n* Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.\n* Known allergy to materials used in the study (adhesive, ECG electrodes)\n* Diagnosed with syncope due to cardiologic causes.\n* Have had a myocardial infarction in the previous 90 days\n* Have been diagnosed with tachycardia that requires medical treatment\n* Experienced complications during previous clinically indicated ARS assessment\n* Are on medications that could affect autonomic function, if considered not safe or unwilling to hold such medications for at least four half-lives prior to testing (judged by the study Principal Investigator)\n* Have any contraindication for tilt test, Valsalva maneuver test or deep breathing test'}, 'identificationModule': {'nctId': 'NCT03721393', 'acronym': 'COST3', 'briefTitle': 'Data Collection - Of Syncope Tilt Table Testing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Data Collection - Of Syncope Tilt Table Testing Study', 'orgStudyIdInfo': {'id': 'C2109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Syncope patients', 'description': 'Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope.', 'interventionNames': ['Device: Wearable heart monitor']}, {'label': 'Group 2: Control patients', 'description': 'Patients that have undergone an ARS assessment and are control subjects.', 'interventionNames': ['Device: Wearable heart monitor']}], 'interventions': [{'name': 'Wearable heart monitor', 'type': 'DEVICE', 'description': 'Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment.', 'armGroupLabels': ['Group 1: Syncope patients', 'Group 2: Control patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Foundation', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Wolfgang Singer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}