Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-07 @ 1:09 PM
Study NCT ID:
NCT03195556
Status:
RECRUITING
Last Update Posted:
2018-08-23
First Post:
2017-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmentation of Limb Perfusion With Contrast Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-05-18', 'releaseDate': '2020-05-12'}, {'resetDate': '2021-03-31', 'mcpReleaseN': 2, 'releaseDate': '2021-03-05'}], 'estimatedResultsFirstSubmitDate': '2020-05-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood flow at 10 min', 'timeFrame': '10 min post-therapeutic ultrasound cavitation.', 'description': 'Change in blood flow in calf skeletal muscle'}, {'measure': 'Change in blood flow at 60 min', 'timeFrame': '60 min post-therapeutic ultrasound cavitation', 'description': 'Change in blood flow in calf skeletal muscle'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '31422129', 'type': 'DERIVED', 'citation': 'Mason OR, Davidson BP, Sheeran P, Muller M, Hodovan JM, Sutton J, Powers J, Lindner JR. Augmentation of Tissue Perfusion in Patients With Peripheral Artery Disease Using Microbubble Cavitation. JACC Cardiovasc Imaging. 2020 Mar;13(3):641-651. doi: 10.1016/j.jcmg.2019.06.012. Epub 2019 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 y.o.\n* For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.\n\nExclusion Criteria:\n\n1. Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \\[NYHA class IV or LVEF \\<30%\\]).\n2. Pregnant or lactating females\n3. Hypersensitivity to any ultrasound contrast agent\n4. Known atrial septal defect or large right to left shunt.\n5. Hemodynamic instability (hypotension with systolic BP \\<90 mm Hg, need for vasopressors)\n6. Evidence for ongoing myocardial ischemia\n7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).'}, 'identificationModule': {'nctId': 'NCT03195556', 'briefTitle': 'Augmentation of Limb Perfusion With Contrast Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Augmentation of Limb Perfusion With Contrast Ultrasound', 'orgStudyIdInfo': {'id': 'IRB00017343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': 'Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.', 'interventionNames': ['Device: Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral Artery Disease', 'description': 'Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.', 'interventionNames': ['Device: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'otherNames': ['Contrast ultrasound'], 'description': 'Ultrasound exposure of Definity microbubbles infused over 10 min. Ultrasound administered at 1.3 MHz, mechanical index of 1.3, and pulsing interval of 10 s.', 'armGroupLabels': ['Healthy subjects', 'Peripheral Artery Disease']}]}, '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': '5034943574'}]}, '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'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-05-12', 'type': 'RELEASE'}, {'date': '2020-05-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jonathan R. Lindner, MD, Professor, Oregon Health and Science University'}}}}