Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-28 @ 7:30 AM
Study NCT ID:
NCT02973633
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2016-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion MRI in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}, {'id': 'C112669', 'term': 'gadolinium DOTA meglumine'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2016-11-19', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myofiber Helix Angle', 'timeFrame': '12 months', 'description': 'The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.'}], 'secondaryOutcomes': [{'measure': 'Correlation of Myofiber Helix Angle and Strain', 'timeFrame': '12 months', 'description': 'The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Remodeling', 'Myocardial Infarction', 'Left Ventricular Hypertrophy', 'Diffusion Tensor MRI'], 'conditions': ['Heart Failure', 'Myocardial Infarction', 'Left Ventricular Hypertrophy']}, 'referencesModule': {'references': [{'pmid': '27681278', 'type': 'RESULT', 'citation': 'Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/radiol.2016152613. Epub 2016 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of water in the heart with MRI will allow its microstructure to be resolved. The investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. Patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the heart to characterize changes in myocardial microstructure over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults with no history of hypertension, diabetes or heart disease\n* Patients with ST Elevation MI within last 6-10 weeks who are angina free, and have been seen by a cardiologist since discharge\n* Patients with episode of heart failure within last 12 months and left ventricular hypertrophy, documented by echocardiogram or MRI.\n\nExclusion Criteria:\n\n1. Presence of metallic foreign bodies/objects\n2. Selected medical devices and implants\n3. Pacemakers, implantable defibrillators, life vests\n4. Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent)\n5. Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months\n6. Atrial fibrillation that is not well rate controlled (heart rate \\>125)\n7. Unstable angina within last 2 months that has not been fully evaluated by a cardiologist\n8. Syncope within last 6 weeks\n9. Hemodynamic instability (Systolic BP less than 100 or greater than 180)\n10. Decompensated heart failure (inability to lie flat and perform a breath-hold).\n11. Glomerular filtration rate (GFR) \\< 60 for those receiving gadolinium.\n12. Labile GFR that is not stable/similar on last 2 measurements (for those receiving gadolinium).\n13. Patients with GFR \\< 20 or on any form of dialysis.\n14. Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)\n15. Recent surgery (within the last 3 months)\n16. Prior stroke with large residual deficit\n17. Presence of liver or respiratory failure\n18. Pregnancy and nursing mothers\n19. Claustrophobia\n20. Known seizure disorder'}, 'identificationModule': {'nctId': 'NCT02973633', 'briefTitle': 'Diffusion MRI in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Diffusion MRI in Heart Failure', 'orgStudyIdInfo': {'id': '2016P001898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers', 'description': 'DTI will be performed in healthy volunteers to characterize normal fiber architecture in the heart and provide a comparison group for the patients imaged in the other arms.', 'interventionNames': ['Device: Diffusion Tensor MRI (DTI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with Recent Myocardial Infarction', 'description': 'Patients with recent ST elevation myocardial infarcts will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with remodeling of the left ventricle.', 'interventionNames': ['Device: Diffusion Tensor MRI (DTI)', 'Drug: Gadolinium DOTA Meglumine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with Left Ventricular Hypertrophy', 'description': 'Patients with left ventricular hypertrophy and a history of heart failure will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with the onset and progression of heart failure.', 'interventionNames': ['Device: Diffusion Tensor MRI (DTI)']}], 'interventions': [{'name': 'Diffusion Tensor MRI (DTI)', 'type': 'DEVICE', 'description': 'Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined.', 'armGroupLabels': ['Healthy Volunteers', 'Patients with Left Ventricular Hypertrophy', 'Patients with Recent Myocardial Infarction']}, {'name': 'Gadolinium DOTA Meglumine', 'type': 'DRUG', 'description': 'Late Gadolinium enhancement', 'armGroupLabels': ['Patients with Recent Myocardial Infarction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'centralContacts': [{'name': 'David E. Sosnovik, MD', 'role': 'CONTACT', 'email': 'sosnovik@nmr.mgh.harvard.edu', 'phone': '617-724-3407'}], 'overallOfficials': [{'name': 'David E. Sosnovik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'David E Sosnovik', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}