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NCT Number: NCT07487961

Assess Abdominal Aortic Diameter in Females

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.

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Key information

Conditions

Aorta Disease Aneurysm Aorta Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location status: Recruiting

Location contact

IRENE FULGHERI

CONTACT

[email protected]

+390255036670

SANTI TRIMARCHI, MD, PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. AP and LL (inner-to-inner and outer-to-outer) measurement in mm at ultrasound of the infrarenal aortic segment

    Time frame: baseline

    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.

Secondary outcomes

  1. association between anamnestic information and the presence of abdominal aortic atherosclerosis

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

CHIARA LOMAZZI, MD

CONTACT

[email protected]

+390255036670

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: AFRODITE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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