Triple-A Barcelona Study

NCT ID: NCT06827652

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2028-12-31

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Sabater-Lleal, PhD

Role: PRINCIPAL_INVESTIGATOR

RESEARCH INSTITUTE/HOSP/SANTA CREU/PAU

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria Sabater-Lleal, PhD

Role: CONTACT

msabater@santpau.cat

+34932919000 ext. 8167

Facility Contacts

Maria Sabater-Lleal, PhD

Role: primary

msabater@santpau.cat

+34932919000 ext. 8167

Other Identifiers

IIBSP-OMI-2019-102

Identifier Type: -

Identifier Source: org_study_id