Aorta DiseaseAFRODITENCT07487961
Assess Abdominal Aortic Diameter in Females
An observational study of Aorta Disease and Aorta Aneurysm, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aorta Disease, Aorta Aneurysm
- How many people
- 652 participants
- Where
- 1 siteItaly
- Study dates
- 29 Sep 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: general population
Who may be able to join
- female sex
- ≥ 50 YO
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
IRENE FULGHERI, +390255036670, irene.fulgheri@policlinico.mi.it
SANTI TRIMARCHI, MD, PHD
About this study
Official 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
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.
Read more
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.
Read the 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.
- Conditions
- Aorta Disease, Aorta Aneurysm
- Medical subject headings
- Aortic Diseases, Aortic Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start29 Sep 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487961
- Sponsor's protocol ID
- 6251
- Acronym
- AFRODITE
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07487961
- Acronym / sponsor ID
- AFRODITE / 6251
- Conditions
- Aorta Disease, Aorta Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general population
Key inclusion criteria (2 listed)
- female sex
- ≥ 50 YO
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
association between anamnestic information and the presence of abdominal aortic atherosclerosis
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorta Disease and Aorta Aneurysm, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHIARA LOMAZZI, MD (+390255036670, chiara.lomazzi@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AP and LL (inner-to-inner and outer-to-outer) measurement in mm at ultrasound of the infrarenal aortic segment (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.