Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT03546933
Status:
TERMINATED
Last Update Posted:
2019-09-18
First Post:
2018-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VitalScan MCG Rule-out Multi-centre Pivotal Study - US
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 651}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "A correction needs to be made to the device's algorithm.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of MCG', 'timeFrame': 'up to 3 month follow-up', 'description': 'Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm'}], 'secondaryOutcomes': [{'measure': 'Proportion of adverse events and types', 'timeFrame': 'up to 3 month follow-up'}, {'measure': 'All-cause mortatility (divided into CV and non-CV causes) proportion', 'timeFrame': 'through 1 week, 3 month follow-up'}, {'measure': '3.Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups', 'timeFrame': 'up to 3 months follow-up'}, {'measure': 'MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses))', 'timeFrame': 'through 1 week, 3 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)\n* 18+ year old male or female\n* Patient is willing and able to give written informed consent\n\nExclusion Criteria:\n\n* ST-segment Elevation MI (STEMI)\n* Clear non-ischemic cause for symptoms (e.g. trauma)\n* Hemodynamic instability on admission (e.g. BP\\>220mmHg systolic \\& \\>110mmHg diastolic, \\<80mmHg systolic \\& \\<40mmHg diastolic, HR\\>160bpm)\n* Ventricular tachycardia or fibrillation that cannot be treated effectively\n* Atrial fibrillation\n* Thoracic metal implants\n* Pacemaker or internal defibrillator\n* Pregnancy (if after 20-week period)\\* or lactation\n* Patient unable to lie down (i.e. supine position) or stay still on the examination bed\n* Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English- speaking relative/translator not available)\n* Patient unable to comply with the requirements of the protocol'}, 'identificationModule': {'nctId': 'NCT03546933', 'acronym': 'MAGNET ACS', 'briefTitle': 'VitalScan MCG Rule-out Multi-centre Pivotal Study - US', 'organization': {'class': 'INDUSTRY', 'fullName': 'Creavo Medical Technologies Ltd'}, 'officialTitle': 'A Prospective Multi-centre Observational Study to Validate the Diagnostic Accuracy of a Transportable Magnetocardiograph Device for Acute Coronary Syndrome (ACS), Focusing on Rule-out Capability, in Patients Who Present to the Emergency Department With Chest Pain Symptoms Consistent With ACS', 'orgStudyIdInfo': {'id': 'CIP 003 (US)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chest pain patients presenting to the ED', 'description': 'All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph.', 'interventionNames': ['Device: VitalScan Magnetocardiograph']}], 'interventions': [{'name': 'VitalScan Magnetocardiograph', 'type': 'DEVICE', 'description': "A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.", 'armGroupLabels': ['Chest pain patients presenting to the ED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267-0769', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Gregory J Fermann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creavo Medical Technologies Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}