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
1 other identifier
observational
652
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2025
CompletedFirst Submitted
Initial submission to the registry
March 6, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
March 27, 2026
March 1, 2026
1.8 years
March 6, 2026
March 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
association between anamnestic information and the presence of abdominal aortic atherosclerosis
baseline
Eligibility Criteria
general population
You may qualify if:
- female sex
- ≥ 50 YO
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2026
First Posted
March 23, 2026
Study Start
September 29, 2025
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03