Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-27 @ 1:22 AM
Study NCT ID:
NCT03358368
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2017-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MCG Post Myocardial Infarction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2017-11-26', 'studyFirstSubmitQcDate': '2017-11-26', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MCG parameter extraction', 'timeFrame': 'From baseline scan', 'description': 'To extract parameters from MCG scans to identify key characteristics (markers) for myocardial infarction'}], 'secondaryOutcomes': [{'measure': 'MCG parameter analysis', 'timeFrame': 'From baseline scan', 'description': 'To use the markers identified to differentiate between abnormal (post MI) images and normal (healthy volunteer) images using evaluation performance measures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The study is being performed to evaluate a new portable medical device, the Creavo Vitalscan Magnetocardiograph (Vitalscan) on patients who have had a confirmed myocardial infarction (heart attack) within the previous 12 weeks.', 'detailedDescription': 'Magnetocardiography (MCG) is a non-contact, passive, imaging technique that detects the magnetic fields generated by the electrical activity of the heart. The MCG technology has been evaluated in several clinical studies, demonstrating its potential usefulness in the detection of patients with stable angina and acute coronary syndrome (ACS), including non-ST segment elevation myocardial infarction (NSTEMI).\n\nPrevious studies have been completed using earlier versions of the Vitalscan device. Results showed that the device could differentiate between patients with confirmed ischaemic heart disease (IHD) and NSTEMI, those with non-IHD experiencing chest pain and healthy (non-ischaemic) control subjects.\n\nThe aim of this pilot study is to assess the difference between abnormal MCG images from patients with a confirmed and recent myocardial infarction (MI)and normal images from previously obtained healthy volunteer controls scanned with the current device, so that comparisons can be made to the data acquired from the previous studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had a confirmed myocardial infarction within 12 weeks of the initial event under the care of South Warwickshire NHS Foundation Trust.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed myocardial infarction within 12 weeks of the initial event\n* Patients admitted to the Coronary Care Unit (CCU) at Warwick Hospital on the point of discharge or patients already discharged from the CCU attending the cardiac rehabilitation classes\n* 18+ year old male or female\n* Patient is willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* Thoracic metal implants (cardiac stents allowed)\n* Pacemaker or internal defibrillator\n* Pregnancy (if after 20-week period)\\* or lactation\n* Patient unable to lie down (i.e. supine position up to a maximum 25 degree tilt) 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\n * There should not be any effect on pregnancy due to the non-invasive nature of the device. Pregnancy after the 20-week period excluded from the study due to the size and position of the foetus and unknown possibility of picking up the foetal heartbeat, rendering the scan non-usable for study requirements'}, 'identificationModule': {'nctId': 'NCT03358368', 'briefTitle': 'MCG Post Myocardial Infarction Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Creavo Medical Technologies Ltd'}, 'officialTitle': 'A Prospective Single-centre Pilot Study to Assess a Magnetocardiograph Device in Patients Following Myocardial Infarction.', 'orgStudyIdInfo': {'id': 'CIP 004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vitalscan', 'type': 'DEVICE', 'description': 'Vitalscan is a magnetocardiograph device'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CV34 5BW', 'city': 'Warwick', 'state': 'Warwickshire', 'country': 'United Kingdom', 'facility': 'South Warwickshire NHS Trust', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}], 'overallOfficials': [{'name': 'Roger Beadle, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Warwickshire NHS Foundation Trust, UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creavo Medical Technologies Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}