Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01182805
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2010-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tkolias@umich.edu', 'phone': '(734) 615-4907', 'title': 'Theodore J. Kolias, MD', 'organization': 'University of Michigan'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Study.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diastolic Circumferential Strain Rate During Isovolumic Relaxation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Diastolic Function', 'description': 'These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \\<= 15 mm Hg).'}, {'id': 'OG001', 'title': 'Grade 1 Diastolic Dysfunction', 'description': 'These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A \\< 1.0).'}, {'id': 'OG002', 'title': 'Grade 2 Diastolic Dysfunction', 'description': 'These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \\> 15 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed from echo obtained at time of enrollment', 'description': 'Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.', 'unitOfMeasure': '1/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.'}, {'type': 'PRIMARY', 'title': 'Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Diastolic Function', 'description': 'These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \\<= 15 mm Hg).'}, {'id': 'OG001', 'title': 'Grade 1 Diastolic Dysfunction', 'description': 'These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A \\< 1.0).'}, {'id': 'OG002', 'title': 'Grade 2 Diastolic Dysfunction', 'description': 'These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP \\> 15 mm Hg).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed from echo obtained at time of enrollment', 'description': 'E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2010-08-12', 'resultsFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-02', 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastolic Circumferential Strain Rate During Isovolumic Relaxation', 'timeFrame': 'Assessed from echo obtained at time of enrollment', 'description': 'Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.'}, {'measure': 'Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler', 'timeFrame': 'Assessed from echo obtained at time of enrollment', 'description': 'E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure, Diastolic']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.\n\nExclusion Criteria:\n\n* Suspected acute ST elevation myocardial infarction.\n* Acute coronary syndrome with active ongoing chest pain\n* Known or suspected acute aortic dissection\n* Known or suspected cardiac tamponade\n* Known history of unoperated constrictive pericarditis\n* Known or suspected severe aortic stenosis or severe mitral regurgitation\n* Heart rhythm other than sinus rhythm on pre-cath EKG\n* Age \\< 18 years old\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01182805', 'acronym': 'RF-SPEED', 'briefTitle': 'Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function', 'orgStudyIdInfo': {'id': 'RF-SPEED'}, 'secondaryIdInfos': [{'id': '5R44HL071379', 'link': 'https://reporter.nih.gov/quickSearch/5R44HL071379', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm study.', 'interventionNames': ['Device: Echocardiography system Ultra DCI Model 5000', 'Device: Echocardiography machine GE Vivid E9', 'Device: Diastolic function assessment']}], 'interventions': [{'name': 'Echocardiography system Ultra DCI Model 5000', 'type': 'DEVICE', 'description': 'Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.', 'armGroupLabels': ['Single arm study.']}, {'name': 'Echocardiography machine GE Vivid E9', 'type': 'DEVICE', 'description': 'Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.', 'armGroupLabels': ['Single arm study.']}, {'name': 'Diastolic function assessment', 'type': 'DEVICE', 'description': 'Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.', 'armGroupLabels': ['Single arm study.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109-5853', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Cardiovascular Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Theodore J Kolias, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pixel Velocity, Inc. / Epsilon Imaging', 'class': 'INDUSTRY'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Theodore J. Kolias', 'investigatorAffiliation': 'University of Michigan'}}}}