Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-07 @ 5:33 AM
Study NCT ID:
NCT04724304
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial blood volume', 'timeFrame': 'Baseline', 'description': 'Ratio in systole and diastole (MBVs/MBVd) by real-time myocardial perfusion echocardiography (RTMPE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to find out the normal amount of blood within the heart muscle and the variations in this blood flow between a cardiac MRI and TTE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Available for testing performed in Rochester, MN.\n* Willing to undergo both an echocardiogram with RTMPE and CMR.\n* Study subject providing consent.\n\nExclusion Criteria:\n\n* Adults \\< 18 years.\n* BMI \\<30 kg/m\\^2.\n* Hypertension.\n* Diabetes Mellitus.\n* Stroke.\n* Cardiomyopathy or structural heart disease.\n* Known coronary artery disease or history of myocardial infarction.\n* Contraindication to echo enhancement agent or gadolinium administration such as an allergy.\n* Renal GFR \\< 50 mL/mL.\n* Females who are pregnant.\n* Subject unwilling to consent.'}, 'identificationModule': {'nctId': 'NCT04724304', 'briefTitle': 'Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Myocardial Blood Volume Measurement by Real-Time Myocardial Perfusion Echocardiography Correlates to Myocardial Compressibility by Cardiac Magnetic Resonance Imaging in Healthy Subjects', 'orgStudyIdInfo': {'id': '20-000936'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy adults', 'description': 'Healthy adults will have blood flow to the heart evaluated using s Real-Time Myocardial Echocardiography (RTMPE) and magnetic resonance image (MRI) to the heart.', 'interventionNames': ['Diagnostic Test: Real-Time Myocardial Echocardiography (RTMPE)', 'Diagnostic Test: Magnetic resonance image (MRI)']}], 'interventions': [{'name': 'Real-Time Myocardial Echocardiography (RTMPE)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Uses sound waves (ultrasound) to produce an images of the heart. During RTMPE a microbubble contrast agent is administered through an intravenous line (IV) to make the images of your heart clearer.', 'armGroupLabels': ['Healthy adults']}, {'name': 'Magnetic resonance image (MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': "Imaging that focuses on the heart or blood vessels to assess size and function of the heart's chambers, thickness and movement of the walls of the heart, and blood flow in the blood vessels.", 'armGroupLabels': ['Healthy adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Courtney Bennett, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Courtney E. Bennett', 'investigatorAffiliation': 'Mayo Clinic'}}}}