Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT01635257
Status:
COMPLETED
Last Update Posted:
2013-03-18
First Post:
2012-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2012-07-01', 'studyFirstSubmitQcDate': '2012-07-04', 'lastUpdatePostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of ultrasound for the diagnosis of pulmonary embolism', 'timeFrame': 'The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.', 'description': 'Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of limb, cardiac, thoracic and multi-organ ultrasound for the diagnosis of pulmonary embolism in the emergency department considering as gold standard the Multidetector Computed Tomography Angiography (MCTPA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary embolism diagnosis', 'ultrasound'], 'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '24092475', 'type': 'DERIVED', 'citation': 'Nazerian P, Vanni S, Volpicelli G, Gigli C, Zanobetti M, Bartolucci M, Ciavattone A, Lamorte A, Veltri A, Fabbri A, Grifoni S. Accuracy of point-of-care multiorgan ultrasonography for the diagnosis of pulmonary embolism. Chest. 2014 May;145(5):950-957. doi: 10.1378/chest.13-1087.'}]}, 'descriptionModule': {'briefSummary': "Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.\n\nMethods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score\\>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients more than 18 years presenting to three emergency departments with clinical suspected pulmonary embolism. Clinical suspected pulmonary embolism is defined as new onset or worsening dyspnea, chest pain, syncope or shock/Hypotension without an alternative obvious cause', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with clinical suspected pulmonary embolism\n* Simplified Well's score\\>4 (PE likely) or D-dimer value ≥500ng/ml\n* Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism\n\nExclusion Criteria:\n\n* Refused consent\n* Less than 18 years old\n* Not possible to perform ultrasound scan within 3 hours before MCTPA"}, 'identificationModule': {'nctId': 'NCT01635257', 'acronym': 'SPES', 'briefTitle': 'Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study', 'orgStudyIdInfo': {'id': '080974'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'suspected pulmonary embolism patients', 'description': "patients with clinical suspicion of PE and with a simplified Well's score\\>4 (PE likely) or with a D-dimer value ≥500ng/ml presenting to the emergency departments of Careggi University Hospital (Firenze), of San Luigi Gonzaga University Hospital (Torino) of Ospedale Pierantoni-Morgagni (Forlì)", 'interventionNames': ['Other: Ultrasound scan']}], 'interventions': [{'name': 'Ultrasound scan', 'type': 'OTHER', 'description': 'A multiorgan ultrasound was performed by an emergency physician sonographer before MCTPA. Pulmonary embolism was considered echographically present if compression ultrasound was positive for deep vein thrombosis or transthoracic-echocardiography was positive for right ventricular dysfunction or at least one pulmonary subpleural infarct was detected with thoracic ultrasound.', 'armGroupLabels': ['suspected pulmonary embolism patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Emergency Department Azienda Ospedaliera Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '47121', 'city': 'Forlì', 'country': 'Italy', 'facility': 'Department of Emergency Medicine, Pierantoni Morgagni Hospital', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '10043', 'city': 'Torino', 'country': 'Italy', 'facility': 'Department of Emergency Medicine, San Luigi Gonzaga University Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Stefano Grifoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Director of Pronto Soccorso generale of AUO Careggi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor Emergency Medicine', 'investigatorFullName': 'Peiman Nazerian', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}