Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-28 @ 5:22 AM
Study NCT ID:
NCT02564133
Status:
TERMINATED
Last Update Posted:
2017-08-09
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip Fracture and Patent Foramen Ovale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with postoperative complications probably related to the presence of a patent foramen ovale', 'timeFrame': 'First postoperative week', 'description': 'Complications probably related to the presence of a patent foramen ovale'}], 'secondaryOutcomes': [{'measure': 'Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale', 'timeFrame': 'First postoperative week', 'description': 'Complications probably not related to the presence of a patent foramen ovale'}, {'measure': 'Number of days before walking without help', 'timeFrame': 'One year'}, {'measure': 'Number of days at home during the first postoperative year', 'timeFrame': 'one year', 'description': 'Number of days of stay at home'}, {'measure': 'Mortality', 'timeFrame': 'Three months and one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.\n\nA patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.\n\nThe hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hip fracture requiring a surgical procedure\n\nExclusion Criteria:\n\n* simultaneous other traumatic lesion'}, 'identificationModule': {'nctId': 'NCT02564133', 'acronym': 'COL-FOP', 'briefTitle': 'Hip Fracture and Patent Foramen Ovale', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?', 'orgStudyIdInfo': {'id': '2012/35'}, 'secondaryIdInfos': [{'id': '2012-A01155-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'detection of a patent foramen ovale', 'interventionNames': ['Device: Transthoracic echocardiography']}], 'interventions': [{'name': 'Transthoracic echocardiography', 'type': 'DEVICE', 'description': 'A transthoracic echocardiography is performed to discover a patent foramen ovale', 'armGroupLabels': ['detection of a patent foramen ovale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92300', 'city': 'Levallois-Perret', 'country': 'France', 'facility': 'Institut Hospitalier Franco-Britannique', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}