Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-29 @ 7:34 AM
Study NCT ID:
NCT02356120
Status:
WITHDRAWN
Last Update Posted:
2016-12-16
First Post:
2015-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2015-01-30', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy of TAPSE (The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis)', 'timeFrame': '0 days', 'description': 'The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis'}], 'secondaryOutcomes': [{'measure': 'Inter-Observer Agreement (To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.)', 'timeFrame': '0 days', 'description': 'To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to evaluate the measurement of tricuspid annular plane systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the pulmonary arteries (CTPA)', 'detailedDescription': 'This will be a prospective observational cohort study aimed at determining the utility and reproducibility of TAPSE, in patients who present to the emergency department with suspected pulmonary embolism (PE). The gold standard diagnostic test for PE is computed tomography of the pulmonary arteries (CTPA). Any patient for whom a CTPA is ordered because of suspected PE is eligible for study inclusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subject population will consist of a convenience sample, taken when study investigators are available, of all those patients for whom suspicion of PE is high enough that their attending physician has ordered a CTPA in the ED', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Concern for PE by attending physician and CTPA ordered\n\nExclusion Criteria:\n\n* If patient is under the age of 18, a prisoner, or a ward of the state\n* CTPA ordered but not performed'}, 'identificationModule': {'nctId': 'NCT02356120', 'briefTitle': 'Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'The Inter-observer Reliability and Diagnostic Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected Pulmonary Embolus in the Emergency Department', 'orgStudyIdInfo': {'id': '1412015010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected Pulmonary Embolus', 'description': 'Patients with suspected pulmonary embolus who are getting a CTPA', 'interventionNames': ['Other: Echocardiogram']}], 'interventions': [{'name': 'Echocardiogram', 'type': 'OTHER', 'description': 'Tricuspid annular plane systolic excursion will by measured by emergency physician performed echocardiogram', 'armGroupLabels': ['Suspected Pulmonary Embolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Chris Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}