Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-01 @ 4:20 AM
Study NCT ID:
NCT02035293
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2014-01-03', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.', 'timeFrame': '27 months'}], 'secondaryOutcomes': [{'measure': "The rate of pulmonary embolism diagnosed during the 3 month follow-up in patients whom pulmonary embolism was initially excluded when they've been included in the study", 'timeFrame': '27 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD Exacerbation', 'Pulmonary embolism', 'Standardized and consensus diagnostic strategy'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Patients Hospitalized for a COPD Exacerbation']}, 'referencesModule': {'references': [{'pmid': '33399840', 'type': 'RESULT', 'citation': 'Couturaud F, Bertoletti L, Pastre J, Roy PM, Le Mao R, Gagnadoux F, Paleiron N, Schmidt J, Sanchez O, De Magalhaes E, Kamara M, Hoffmann C, Bressollette L, Nonent M, Tromeur C, Salaun PY, Barillot S, Gatineau F, Mismetti P, Girard P, Lacut K, Lemarie CA, Meyer G, Leroyer C; PEP Investigators. Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms. JAMA. 2021 Jan 5;325(1):59-68. doi: 10.1001/jama.2020.23567.'}]}, 'descriptionModule': {'briefSummary': 'A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized for a COPD exacerbation\n* COPD previously diagnosed\n\nExclusion Criteria:\n\n* Allergy to iodinated contrast\n* Creatinine clearance \\< 30 mL / min\n* Patient hospitalized for exacerbation of COPD for more than 48 hours\n* Pneumothorax\n* Exams impossible to be performed\n* Pregnancy\n* Life expectancy \\< 3 months\n* Patients already receiving anticoagulant therapy for another reason (mechanical valve, cardiac arrhythmia).'}, 'identificationModule': {'nctId': 'NCT02035293', 'acronym': 'PEP', 'briefTitle': "Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': "Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)", 'orgStudyIdInfo': {'id': 'PEP'}, 'secondaryIdInfos': [{'id': 'RB 13-087 [CHRU Brest]'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PEP', 'description': 'No drug and no placebo were used in this study. For all the patients who participated at the study PEP, only following exams must be performed: a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a chest multidetector-row CT angiography and venous ultrasound of the lower limbs', 'interventionNames': ['Other: PEP']}], 'interventions': [{'name': 'PEP', 'type': 'OTHER', 'otherNames': ['No drug and no placebo were used in this study. For all the patients who participated at the study PEP, only exams must be performed;'], 'armGroupLabels': ['PEP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29240', 'city': 'Brest', 'country': 'France', 'facility': 'HIA', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'CH de Cornouaille Quimper', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Francis COUTURAUD, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}