Clinical trial NCT06827652: Triple-A Barcelona Study
Official title: Observational Prospective Study of Individuals with Abdominal Aortic Aneurysm (AAA) to Monitor AAA Growth and Rupture Risk.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: Aneurysm, Aorta, risk
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Individuals with a diagnosis of AAA visiting at Hospital de Sant Pau or Hospital del Mar in Barcelona.

Brief summary: The Triple-A Barcelona Study (TABS), is a new hospital-based longitudinal study recruiting consecutive individuals with Abdominal Aortic Aneurysm (AAA) in Barcelona. Individuals that have at least one measurement of the abdominal aortic diameter, either by computed tomography scan or by ultrasound, along with anthropometric, clinical information, and blood samples for most follow-up visits are recruited.

Detailed description: The Triple-A Barcelona Study (TABS) is a prospective longitudinal registry started in 2019. All individuals identified incidentally with AAA, defined as those with dilation in infrarenal abdominal aorta with a diameter greater than 30 mm13 that visit the Vascular and Endovascular Surgery Units of Hospital de la Santa Creu i Sant Pau and Hospital del Mar (Barcelona, Spain) from 2020 to the present are invited to participate to the project. Patients who did not consent to participation were not considered for enrollment. Upon enrollment, participant's medical history was carefully reviewed, and all previous measures of aortic diameter and available clinical information was included retrospectively in the database. All participants have at least one measurement of the abdominal aortic diameter, either by computed tomography scan (CT-scan) or by ultrasound along with anthropometric and clinical information, and blood samples for most follow-up visits. The first measurement was considered as the baseline. All measurements following the baseline measurement were used until aortic repair or rupture, or death. Individuals that were excluded from surgery after they exceeded the surgical threshold (due to concomitant pathology, AAA anatomy or patient rejection to surgery) were also considered for inclusion, and their retrospective data, if existing, was recorded. All patients were asked for an informed consent to participate in this study, and to be included in a clinical database. Type B dissections that progress to AAA, saccular aneurysms, mycotic aneurysms, visceral aneurysms or thoracic aneurysms were excluded. Aortic diameter was assessed using either ultrasound or CT-scan images.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of abdominal aortic aneurysm
* infrarenal abdominal aortic diameter greater than 30 mm

Exclusion Criteria:

* Type B dissections that progress to AAA
* saccular aneurysms
* mycotic aneurysms
* visceral aneurysms
* thoracic aneurysms.

Primary outcomes:
measure: Abdominal Aortic diameter
timeFrame: baseline, through study completion (every 2 years on average), pre-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
affiliation: RESEARCH INSTITUTE/HOSP/SANTA CREU/PAU
name: Maria Sabater-Lleal, PhD
role: PRINCIPAL_INVESTIGATOR
References: