Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT01882634
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2013-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1010}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Associated risk factors to abdominal aortic aneurysm', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.', 'detailedDescription': "Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 60 years or more\n* Attending at primary health care center for any complaint\n\nExclusion Criteria:\n\n* Subjects being hemodynamically unstable at presentation\n* Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique\n* Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.'}, 'identificationModule': {'nctId': 'NCT01882634', 'acronym': 'BarcelonAAA', 'briefTitle': 'Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care', 'organization': {'class': 'OTHER', 'fullName': "Consorci d'Atenció Primària de Salut de l'Eixample"}, 'officialTitle': 'Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care', 'orgStudyIdInfo': {'id': 'CP041192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound arm', 'interventionNames': ['Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric)']}], 'interventions': [{'name': 'Ultrasound (Trademark:VScan; Manufacturer:General Electric)', 'type': 'DEVICE', 'description': 'Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm)', 'armGroupLabels': ['Ultrasound arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Primary Care Center Les Corts', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Primary Care Center Casanova', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Primary Care Center Comte Borrell', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Antoni Sisó Almirall, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE)"}, {'name': 'Daniel Cararach Salami, MD', 'role': 'STUDY_CHAIR', 'affiliation': "General Practitioner. Primary Care Center Les Corts, Consorci d'Atenció Primària de Salut Eixample (CAPSE)"}, {'name': 'Alfonso Pérez Jiménez, MD', 'role': 'STUDY_CHAIR', 'affiliation': "General Practitioner. Primary Care Center Casanova, Consorci d'Atenció Primària de Salut Eixample (CAPSE)"}, {'name': 'Marta Navarro González, MD', 'role': 'STUDY_CHAIR', 'affiliation': "General Practitioner. Primary Care Center Comte Borrell, Consorci d'Atenció Primària de Salut Eixample (CAPSE)"}, {'name': 'Rosa Gilabert Solé, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic'}, {'name': 'Concepció Bru Saumell, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic'}, {'name': 'Vicenç Riambau Alonso, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chief of Vascular Surgery Division, Thorax Institute, Hospital Clinic'}, {'name': 'Laura Sebastián Montal, MD', 'role': 'STUDY_CHAIR', 'affiliation': "General Manager in Consorci d'Atenció Primària de Salut Eixample (CAPSE)"}, {'name': 'Jaume Benavent Àreu, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Director d'Afers Assistencials. Catalan Institute of Health. Ministry of Health. Catalonia, Spain."}, {'name': 'Belchin Kostov, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Statistician. Transverse Group for Research in Primary Care, IDIBAPS.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci d'Atenció Primària de Salut de l'Eixample", 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research', 'investigatorFullName': 'Dr. Antoni Siso Almirall', 'investigatorAffiliation': "Consorci d'Atenció Primària de Salut de l'Eixample"}}}}