Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:58 AM
Study NCT ID:
NCT07487961
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Abdominal Aortic Diameter in Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 652}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AP and LL (inner-to-inner and outer-to-outer) measurement in mm at ultrasound of the infrarenal aortic segment', 'timeFrame': 'baseline', 'description': 'Association between medical history and the presence of abdominal aortic aneurysm, assessed in millimeters, through anteroposterior \\[AP\\] and laterolateral \\[LL\\] measurements of the infrarenal segment.'}], 'secondaryOutcomes': [{'measure': 'endpoint 2', 'timeFrame': 'baseline', 'description': 'association between anamnestic information and the presence of abdominal aortic atherosclerosis, through the quantification of calcifications (none, mild, significant) of the subrenal tract'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aorta Disease', 'Aorta Aneurysm']}, 'descriptionModule': {'briefSummary': 'Female subjects aged 50 years or older will be enrolled. Biometric data (measurements) of the aorta and iliac vessels, demographic data, pathophysiological history, and data relating to menarche, pregnancy/infertility, and menopause will be collected.\n\nThe aortic diameter measurement protocol will follow standard clinical practice. Measurements will be performed by placing the probe on an axis perpendicular to the aortic axis, manually positioning the calipers in the antero-posterior and lateral-lateral directions, recording both the outer-to-outer (OTO) and inner-to-inner (ITI) diameters. Additionally, the presence of thrombus and/or calcifications and the outer-to-outer (OTO) measurement of the common iliac arteries will be detected.\n\nPrimary objective: Definition of the ultrasound diameter of the abdominal aorta in the female population. Secondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (aneurysm) in the female population.\n\nSecondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (atherosclerosis) in the female population.', 'detailedDescription': "Cardiovascular diseases are the leading cause of morbidity and mortality among women in the Western world, although until a few decades ago they were considered a male prerogative. Indeed, most studies have been conducted on middle-aged Caucasian men, despite women representing more than 50% of the world's population. Clinical trials dedicated to women have long focused almost exclusively on breast and gynecological conditions, and only in recent years has medicine increasingly developed the concept of gender, seeking to draw attention to the differences in prevalence, treatment, and outcomes of conditions common to both sexes.\n\nRegarding aortic disease, the literature is still in its infancy, and the guidelines highlight the need for greater understanding of gender. To date, for example, it is known that for abdominal aortic aneurysms, annual aneurysm growth is equal in both genders. However, when a diameter of 5.5 cm is reached, which is the threshold for surgical treatment, women have a four-fold higher risk of rupture than men. This finding, directly related to biometric data for women, for which the epidemiological values are not yet known, could provide a key to understanding this increased risk.\n\nFurthermore, increasingly evident in the literature is the relationship between cardiovascular disease and hormonal status, whose cycles vary at different stages of life. Estrogen is known to have a protective role for the cardiovascular system, and a reduction, or early loss, of this hormonal protection could be associated with an increased incidence of the disease.\n\nOur study therefore aims to analyze and highlight the biometric differences of the abdominal aorta in relation to gender and its specific characteristics."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'general population', 'genderDescription': 'female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female sex\n* ≥ 50 YO\n\nExclusion Criteria:\n\n* \\< 50 years\n* Previous diagnosis of abdominal/thoracic aneurysm disease\n* Subjects who have previously undergone surgery (both open and endovascular) on the thoracic and/or abdominal aorta\n* Presence of mental disability and/or inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07487961', 'acronym': 'AFRODITE', 'briefTitle': 'Assess Abdominal Aortic Diameter in Females', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': "Studio Osservazionale Prospettico Multicentrico nazionAle Nel Sesso Femminile peR la valutaziOne Del DIametro Dell'aorTa addominalE - A National, Multicenter, Prospective Observational Study in Females to Assess Abdominal Aortic Diameter", 'orgStudyIdInfo': {'id': '6251'}}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'IRENE FULGHERI', 'role': 'CONTACT', 'email': 'irene.fulgheri@policlinico.mi.it', 'phone': '+390255036670'}, {'name': 'SANTI TRIMARCHI, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'CHIARA LOMAZZI, MD', 'role': 'CONTACT', 'email': 'chiara.lomazzi@policlinico.mi.it', 'phone': '+390255036670'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}