Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-03-14 @ 6:59 AM
Study NCT ID:
NCT02141269
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of HHE and TTE results', 'timeFrame': '1 time', 'description': 'Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transthoracic echocardiogram', 'Hand-held Echocardiography'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).\n\nThe investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.', 'detailedDescription': "A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.\n\nWe are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.\n\nThis study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:\n\n1. Ejection fraction: estimates how well the heart is squeezing/functioning.\n2. Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.\n3. Left ventricular end-diastolic dimension: allows us to see if the heart is dilated\n4. Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.\n5. Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.\n6. Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.\n7. Pericardial effusion: excessive fluid in the sack around the heart.\n\nThe images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.\n\nA comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatient and outpatient subjects with an order for a routine transthoracic echocardiogram based on clinical indications.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.\n2. Vscan images will be obtained to evaluate multiple parameters (noted on research summary).\n3. Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.\n4. Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.\n\nExclusion Criteria:\n\n1. Subjects who had a limited transthoracic echocardiography (i.e limited views)\n2. Vscan imaging not attempted for a certain parameter'}, 'identificationModule': {'nctId': 'NCT02141269', 'briefTitle': 'Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Translational Science Institute'}, 'officialTitle': 'Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting', 'orgStudyIdInfo': {'id': '12-5906'}}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Eric Topol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Translational Science Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Topol, MD', 'investigatorAffiliation': 'Scripps Translational Science Institute'}}}}