Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07218705
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Of MCG In Cardiac Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-10-16', 'studyFirstSubmitQcDate': '2025-10-16', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Receiver Operating Characteristic (ROC) curve', 'timeFrame': 'Baseline, 6 Months, 12 Months, 18 Months', 'description': 'Receiver Operating Characteristic (ROC) curve is used to compare true positive rate vs false positive rate. This will be used to determine the sensitivity, specificity, and overall effectiveness of MCG.'}, {'measure': 'Area Under the Curve (AUC) Magnetocardiography', 'timeFrame': 'Baseline, 6 Months, 12 Months, 18 Months', 'description': 'Area Under the Curve (AUC) will be measured by mg\\*h/L.'}, {'measure': 'Area Under the Curve (AUC) Electrocardiogram', 'timeFrame': 'Baseline, 6 Months, 12 Months, 18 Months', 'description': 'Area Under the Curve (AUC) will be measured by mg\\*h/L.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyloidosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this observational study is to evaluate the utility of magnetocardiography (MCG) in diagnosing and monitoring disease progression in patients with amyloidosis, and to assess its effectiveness in comparison to other modalities, such as ECG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study candidates may be identified and recruited in one of the following ways:\n\n* Amyloid Clinic (or other cardiology specialty clinics)\n* In-patient service at the study institution.\n* From the Principal Investigator or Co-Investigator clinical practices\n* Referral from other hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Age ≥ 18 years on the date of consent\n2. Ability for participant to comply with study requirements\n3. Written informed consent\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding\n2. Having an active atrial fibrillation episode as seen on most current 12-lead ECG\n3. Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillator).\n4. External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan\n5. Inability to lie down in a supine/inclined position and stay still on the examination bed\n6. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol"}, 'identificationModule': {'nctId': 'NCT07218705', 'briefTitle': 'A Study Of MCG In Cardiac Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective Study of Magnetocardiography for Disease Detection and Monitoring Treatment Outcomes in Amyloidosis', 'orgStudyIdInfo': {'id': '25-005053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with amyloidosis', 'interventionNames': ['Device: SandboxAQ CardiAQ Magnetocardiography']}], 'interventions': [{'name': 'SandboxAQ CardiAQ Magnetocardiography', 'type': 'DEVICE', 'description': 'Magnetocardiography is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart.', 'armGroupLabels': ['Patients with amyloidosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Structural Heart Research Team', 'role': 'CONTACT', 'email': 'konwinski.craig@mayo.edu', 'phone': '(507) 255-6133'}, {'name': 'Mohamad Adnan Alkhouli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Andy Dang', 'role': 'CONTACT', 'email': 'dang.phong@mayo.edu', 'phone': '507-255-7752'}], 'overallOfficials': [{'name': 'Mohamad Alkhouli, M.D., M.B.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamad Adnan Alkhouli', 'investigatorAffiliation': 'Mayo Clinic'}}}}