Assess Abdominal Aortic Diameter in Females (AFRODITE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aorta Aneurysm; Aorta Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 652

Contacts and Locations

• Study Contact: Name: CHIARA LOMAZZI, MD; Phone Number: +390255036670; Email: chiara.lomazzi@policlinico.mi.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Principal Investigator: SANTI TRIMARCHI, MD, PHD
    • Contact: IRENE FULGHERI; Phone Number: +390255036670; Email: irene.fulgheri@policlinico.mi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

general population

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AP and LL (inner-to-inner and outer-to-outer) measurement in mm at ultrasound of the infrarenal aortic segment	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association between anamnestic information and the presence of abdominal aortic atherosclerosis	association between anamnestic information and the presence of abdominal aortic atherosclerosis, through the quantification of calcifications (none, mild, significant) of the subrenal tract	baseline

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Diseases
• Other Study ID Numbers: 6251

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No