Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05868902
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Magnetocardiography', 'Coronary Ischemia'], 'conditions': ['Coronary; Ischemic']}, 'descriptionModule': {'briefSummary': 'A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women age 40 and up with suspected or confirmed coronary ischemia who are scheduled to undergo diagnostic cardiac PET, for non-emergent diagnostic purposes at an enrolling clinical trial center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to provide informed consent\n* Male or female, aged 40 and up (inclusive) at the time of enrollment\n* Clinical suspicion of myocardial ischemia that clinician desired cardiac PET\n* Completed cardiac PET within 2 weeks prior to study enrollment\n\nExclusion Criteria:\n\n* Patients unable to fit into CardioFlux device.\n* Patients unable to lie supine for 5 minutes.\n* Patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators). NOTE: Sternotomy wires stents are acceptable\n* Ongoing atrial fibrillation or atrial flutter\n* Life expectancy \\<1 yrs. due to non-cardiovascular comorbidity'}, 'identificationModule': {'nctId': 'NCT05868902', 'acronym': 'Magneto-PET', 'briefTitle': 'A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genetesis Inc.'}, 'officialTitle': 'A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.', 'orgStudyIdInfo': {'id': '1000-8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Negative Cardiac PET', 'description': 'Participants without clinical significant findings for coronary ischemia on cardiac PET scan.', 'interventionNames': ['Device: CardioFlux Magnetocardiography']}, {'label': 'Positive Cardiac PET', 'description': 'Participants with findings indicative of coronary ischemia on cardiac PET scan.', 'interventionNames': ['Device: CardioFlux Magnetocardiography']}], 'interventions': [{'name': 'CardioFlux Magnetocardiography', 'type': 'DEVICE', 'description': 'The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)', 'armGroupLabels': ['Negative Cardiac PET', 'Positive Cardiac PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Rosser', 'role': 'CONTACT', 'email': 'rosserc@ccf.org', 'phone': '(216) 444-4372'}, {'name': 'Wael Jaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Dymacek', 'role': 'CONTACT', 'email': 'allison.dymacek@ketteringhealth.org'}, {'name': 'Damien Valencia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kettering Health', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}], 'centralContacts': [{'name': 'Zoe E Swann, PhD', 'role': 'CONTACT', 'email': 'zoe.swann@genetesis.com', 'phone': '4802868695'}, {'name': 'Robert Takla, MD', 'role': 'CONTACT', 'email': 'robert.takla@genetesis.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genetesis Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}