Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT03525535
Status:
TERMINATED
Last Update Posted:
2019-09-16
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients
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': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal investigator departure without possible replacement', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-13', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary embolism prevalence', 'timeFrame': '24 month', 'description': 'Prevalence rate of pulmonary embolism among patient hospitalized for syncope and diagnosed with ventilation/perfusion scan or CT scan.'}], 'secondaryOutcomes': [{'measure': "Assess the impact of the Prandoni's recommendations on the paraclinical evaluations", 'timeFrame': '24 month', 'description': "Number of CT-scans that are made systematically since the Prandoni's recommendations are applied in the hospital"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the prevalence rate of pulmonary embolism among not anticoagulated patient older than 75 years old admitted with syncope and hospitalised in the Toulon Hospital', 'detailedDescription': 'This study will be proposed to every patient that correspond to eligibility criteria. Will be included only those who are not opposed to the collection of their data.\n\nThe data collected will come from the routine care such as medical history, clinical datas, imaging data… The number of pulmonary imaging will be assessed before the diagnostic strategy proposed by Dr Prandoni and after the application of this strategy thanks to a questionnaire to physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male or female over 75 years old without anticoagulated treatment hospitalized for syncope symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female over 75 years-old\n* Emergency consult resulting on an hospitalization in the geriatric service or in the internal medicine service\n* Hospitalised in the Centre Hospitalier Intercommunal de Toulon for syncope, presenting these symptoms:\n* Loss of consciousness with quick return to normal (less than one minute)\n* Spontaneous resolution\n\nExclusion Criteria:\n\n* history of syncope\n* other loss of consciousness (epilepsy, stroke, head trauma)\n* anticoagulated treatment\n* patient's objection"}, 'identificationModule': {'nctId': 'NCT03525535', 'acronym': 'MAXIME', 'briefTitle': 'Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer'}, 'officialTitle': 'MeAsurement of uneXpected Acute Pulmonary embolIsM Among Not Anticoagulated Patients Older Than 75 Years Admitted With Syncope.', 'orgStudyIdInfo': {'id': '2017-CHITS-04'}, 'secondaryIdInfos': [{'id': '2017-A01197-46', 'type': 'OTHER', 'domain': 'Id-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary embolism', 'description': 'data from routine care will be collected for patient eligible and willing to participate', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'data from patient included will be collected during the study', 'armGroupLabels': ['Pulmonary embolism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83500', 'city': 'La Seyne-sur-Mer', 'state': 'Var', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Toulon La Seyne sur Mer', 'geoPoint': {'lat': 43.10322, 'lon': 5.87816}}], 'overallOfficials': [{'name': 'Benoit Faucher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Intercommunal Toulon La Seyne sur Mer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}