Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT05506059
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular 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': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': "The doctor's doing the ultrasounds will be blinded to each other's measurements and to the patient's past medical history"}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians', 'timeFrame': 'During procedure', 'description': 'Two physicians will use the same ultrasound device to measure the E-Point Septal Separation (EPSS) on the same patients. EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. The mean change in EPSS measurements in millimeter will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.', 'timeFrame': 'During procedure', 'description': 'Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram. LVEF (in %) will be estimated from ultrasound using the formula = 75.5 - (2.5 x E-Point Septal Separation in millimeters)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke Volume', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.', 'detailedDescription': 'This research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. Results from the two doctors will be compared to see how similar they are. This research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors.\n\nThe doctors will use ultrasound of the heart to measure E-Point Septal Separation (EPSS). EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. EPSS is measured in millimeters (mm). EPSS can estimate left ventricular ejection fraction (LVEF) as a measure of how well the heart pumps blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care\n* Age 18 or over\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Pediatrics (age \\<18 years old).\n* No cardiac-altering intervention performed between examiners.\n* Unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root.\n* Transthoracic echocardiogram (TTE) more than the next day after EPSS is performed (for secondary outcome).\n* Female with known pregnancy.\n* Prisoner\n* Prior cardiac surgery'}, 'identificationModule': {'nctId': 'NCT05506059', 'acronym': 'BES2T', 'briefTitle': 'Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function', 'organization': {'class': 'OTHER', 'fullName': 'The Guthrie Clinic'}, 'officialTitle': '"BES2T" (Bedside E-point Septal Separation Test) for Emergency Medicine Residents', 'orgStudyIdInfo': {'id': '2206-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Volunteer', 'description': 'Healthy volunteers over the age of 18 who consent to two ultrasounds.', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'ED patient with planned heart echocardiogram', 'description': 'Patients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will have ultrasounds of the heart by two different emergency medicine doctors.', 'armGroupLabels': ['ED patient with planned heart echocardiogram', 'Healthy Volunteer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Robert Packer Hospital', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}], 'overallOfficials': [{'name': 'Dean Licurgo, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Guthrie Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Guthrie Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}