Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT03009266
Status:
UNKNOWN
Last Update Posted:
2018-08-23
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Memory Imaging With Myocardial Contrast Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C069727', 'term': 'Sonazoid'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose optimization', 'timeFrame': '3 months', 'description': 'Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention'}, {'measure': 'Detection of Ischemia', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '34763776', 'type': 'DERIVED', 'citation': 'Davidson BP, Hodovan J, Layoun ME, Golwala H, Zahr F, Lindner JR. Echocardiographic Ischemic Memory Molecular Imaging for Point-of-Care Detection of Myocardial Ischemia. J Am Coll Cardiol. 2021 Nov 16;78(20):1990-2000. doi: 10.1016/j.jacc.2021.08.068.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'NORMAL CONTROL GROUP\n\nInclusion Criteria:\n\n* Normal control individuals\n\nExclusion Criteria:\n\n* History of cardiovascular disease (coronary artery disease, MI, peripheral artery disease)\n* allergy to eggs or ultrasound contrast agents\n* known or detected right to left shunt\n* presence of a wall motion abnormality\n* pregnancy\n\nACS GROUP\n\nInclusion Criteria:\n\n* Patients with diagnosis of acute coronary syndrome with either unstable angina or non-ST-elevation MI\n* Referred for primary percutaneous intervention\n* At least 1 high risk features (ST changes, positive troponin, wall motion abnormality)\n\nExclusion Criteria:\n\n* allergy to eggs or ultrasound contrast agents\n* hemodynamic instability or shock\n* known or detected right to left shunt\n* pregnancy\n* multivessel CAD requiring multivessel PCI'}, 'identificationModule': {'nctId': 'NCT03009266', 'briefTitle': 'Ischemic Memory Imaging With Myocardial Contrast Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Ischemic Memory Imaging With MCE', 'orgStudyIdInfo': {'id': 'IRB00016794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal controls', 'description': 'Normal controls who will undergo dose-ranging studies to determine the optimal dose of phosphatidylserine-containing microbubbles that does not produce delayed myocardial opacification on myocardial contrast echocardiography (MCE).', 'interventionNames': ['Drug: Sonazoid']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with ACS', 'description': 'Subjects with ACS who have undergone primary percutaneous intervention in whom MCE with phosphatidylserine-containing microbubbles will be performed to determine whether the risk area can be detected and spatially defined.', 'interventionNames': ['Drug: Sonazoid']}], 'interventions': [{'name': 'Sonazoid', 'type': 'DRUG', 'description': 'Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid', 'armGroupLabels': ['Normal controls', 'Patients with ACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan R Lindner, MD', 'role': 'CONTACT', 'email': 'lindnerj@ohsu.edu', 'phone': '503-494-8750'}, {'name': 'Jonathan R Lindner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Davidson, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'OHSU', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Jonathan R Lindner, MD', 'role': 'CONTACT', 'email': 'lindnerj@ohsu.edu', 'phone': '5034949191'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan R. Lindner, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}