Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 6:22 PM
Study NCT ID:
NCT06095557
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2023-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MCG Discovery Study in Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% analyzable Sandbox MCG data', 'timeFrame': 'during the procedure (MCG scan)', 'description': '% Sandbox MCG data collected and suitable for analysis'}], 'secondaryOutcomes': [{'measure': 'Sandbox MCG safety', 'timeFrame': '30 days', 'description': 'Device-related adverse events'}, {'measure': 'Characterization of scan results that may differentiate between high risk and low risk ACS patients', 'timeFrame': 'during the procedure (MCG scan)', 'description': 'Signal Noise Ratio of ECG features'}, {'measure': 'Characterization of scan results that may differentiate between high risk and low risk ACS patients', 'timeFrame': 'during the procedure (MCG scan)', 'description': 't-wave field maximum angle'}, {'measure': 'Characterization of scan results that may differentiate between high risk and low risk ACS patients', 'timeFrame': 'during the procedure (MCG scan)', 'description': 'heartbeats needed to obtain signal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['magnetocardiography', 'MCG'], 'conditions': ['ACS - Acute Coronary Syndrome', 'NSTEMI - Non-ST Segment Elevation MI']}, 'descriptionModule': {'briefSummary': 'This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presents to ED with symptoms of Acute Coronary Syndrome (ACS)\n* Can provide written consent\n\nExclusion Criteria:\n\n* Presents to ED with ST-Elevation Myocardial Infarction (STEMI)\n* Presents to ED with Atrial Fibrillation\n* Clear non-ischemic cause for symptoms (i.e. trauma)\n* Active thoracic metal implants'}, 'identificationModule': {'nctId': 'NCT06095557', 'briefTitle': 'MCG Discovery Study in Emergency Departments', 'organization': {'class': 'INDUSTRY', 'fullName': 'SB Technology, Inc.'}, 'officialTitle': 'Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)', 'orgStudyIdInfo': {'id': 'SB-ACS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sponsor MCG device', 'description': 'All participants will receive a scan from the Sponsor MCG device', 'interventionNames': ['Device: Sponsor MCG device']}], 'interventions': [{'name': 'Sponsor MCG device', 'type': 'DEVICE', 'description': 'unshielded device measuring cardiac magnetic fields', 'armGroupLabels': ['Sponsor MCG device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Kit Yee Au-Yeung, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SB Technology, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Technology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}