Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT01248533
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2016-03-30
First Post:
2010-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2010-11-11', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Aortic Aneurysm (AAA)', 'timeFrame': 'Yearly the number of patients with AAA among the screened population will be assessed during the inclusion period of 18 years..', 'description': 'AAA definition: diameter equal or more than 30 mm. The number of identified patients with AAA will be yearlig assessed.'}], 'secondaryOutcomes': [{'measure': 'Peripheral Arterial Disease (PAD)', 'timeFrame': 'Yearly the number of patients with PAD among the screened poplulation will be assessed during the inclusion period of 18 years.', 'description': 'Investigate the prevalence of PAD among patients with AAA defined as having Ankle-Arm Index (AAI) less than 0.9. The number of these patients will be assessed yearly.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abdominal aortic aneurysm, atherosclerosis'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.', 'detailedDescription': 'The invited population will be offered ultrasound investigation of their abdominal aorta. Further information regarding risk factors will be noted and measurement of ankle-brachial index will be measured/calculated. A further step in the future will be to sample blood with focus on different cytokines and genmediators.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '65 year old males in Oslo', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 65 years\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01248533', 'acronym': 'AAAscreening', 'briefTitle': 'Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Screening for Abdominal Aortic Aneurysm', 'orgStudyIdInfo': {'id': '2009/866'}}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All data are entered into the Electronic Patient Journal of Oslo University Hospital (DIPS)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor dr.med.', 'investigatorFullName': 'Jorgen J Jorgensen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}