Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 6:01 AM
Study NCT ID:
NCT03657992
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE', 'timeFrame': 'April 2011 to December 2016', 'description': 'positive, negative, or non-conclusive'}], 'secondaryOutcomes': [{'measure': 'Risk of thromboembolic events (i.e. objectively confirmed pulmonary embolism or proximal deep vein thrombosis) during the 3-month follow-up period in patients left untreated based on a negative SPECT V/Q.', 'timeFrame': 'up to 3 Months following the date of the SPECT V/Q scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016\n\nExclusion Criteria:\n\n* Patient under legal or judicial protection\n* Patient opposed to the use of his medical data for research.'}, 'identificationModule': {'nctId': 'NCT03657992', 'acronym': 'TOMOBS', 'briefTitle': 'Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016', 'orgStudyIdInfo': {'id': 'TOMOBS (29BRC18.0017)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}