Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-26 @ 6:38 PM
Study NCT ID:
NCT01558518
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2012-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Handheld Echocardiography in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2012-03-17', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Handheld echocardiography', 'V-scan', 'Handheld ultrasound', 'Portable ultrasound'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '24684783', 'type': 'DERIVED', 'citation': 'Cullen MW, Blauwet LA, Vatury OM, Mulvagh SL, Behrenbeck TR, Scott CG, Pellikka PA. Diagnostic capability of comprehensive handheld vs transthoracic echocardiography. Mayo Clin Proc. 2014 Jun;89(6):790-8. doi: 10.1016/j.mayocp.2013.12.016. Epub 2014 Mar 29.'}]}, 'descriptionModule': {'briefSummary': "Transthoracic echocardiography (TTE) represents an established and fundamental tool for the evaluation of patients with known or suspected cardiovascular disease. Recently, manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a physician's lab coat. Studies assessing these handheld devices have several limitations. While they have generally evaluated the handheld devices favorably, previous studies has not consistently studied handheld devices under the best possible clinical conditions and have not necessarily highlighted the devices' limitations.\n\nIn this proposal, we seek to analyze the applicability of handheld echocardiograms to standard clinical practice. The investigators plan to use trained sonographers to perform handheld examinations on patients referred for TTE without established cardiovascular disease. The handheld images will be interpreted by experienced, consultant-level echocardiographers. The investigators then plan to compare findings from the handheld echocardiogram to the patient's standard clinical TTE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to the Mayo Clinic Echocardiography Laboratory', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Adult patients referred for a resting transthoracic echocardiogram.\n\nExclusion criteria\n\n* Referral for quantitative assessment of valvular heart disease\n* Referral for strain imaging\n* Referral for measurement of left atrial mechanical function or cardiac resynchronization studies\n* Known diagnosis of congenital heart disease, restrictive cardiomyopathy, constrictive pericardial disease, or pulmonary hypertension\n* Patients who have received left ventricular assist devices or those who have undergone cardiac transplants'}, 'identificationModule': {'nctId': 'NCT01558518', 'briefTitle': 'Handheld Echocardiography in Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Handheld Echocardiography in Clinical Practice', 'orgStudyIdInfo': {'id': '11-008019'}}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Patricia Pellikka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor of Medicine', 'investigatorFullName': 'Patricia A. Pellikka', 'investigatorAffiliation': 'Mayo Clinic'}}}}