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Assess Abdominal Aortic Diameter in Females

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07487961
Acronym
AFRODITE
Enrollment
652
Registered
2026-03-23
Start date
2025-09-29
Completion date
2027-07-30
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aorta Aneurysm, Aorta Disease

Brief summary

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. The 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. Primary 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. Secondary objective: Identification of any sex-specific risk factors associated with abdominal aortic disease (atherosclerosis) in the female population.

Detailed description

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. Regarding 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. Furthermore, 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. Our study therefore aims to analyze and highlight the biometric differences of the abdominal aorta in relation to gender and its specific characteristics.

Interventions

None listed

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* female sex * ≥ 50 YO

Exclusion criteria

* \< 50 years * Previous diagnosis of abdominal/thoracic aneurysm disease * Subjects who have previously undergone surgery (both open and endovascular) on the thoracic and/or abdominal aorta * Presence of mental disability and/or inability to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
AP and LL (inner-to-inner and outer-to-outer) measurement in mm at ultrasound of the infrarenal aortic segmentbaselineAssociation between medical history and the presence of abdominal aortic aneurysm, assessed in millimeters, through anteroposterior \[AP\] and laterolateral \[LL\] measurements of the infrarenal segment.

Secondary

MeasureTime frameDescription
association between anamnestic information and the presence of abdominal aortic atherosclerosisbaselineassociation between anamnestic information and the presence of abdominal aortic atherosclerosis, through the quantification of calcifications (none, mild, significant) of the subrenal tract

Countries

Italy

Contacts

CONTACTCHIARA LOMAZZI, MD
chiara.lomazzi@policlinico.mi.it+390255036670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026