Triple-A Barcelona Study (TABS)

Observational Prospective Study of Individuals with Abdominal Aortic Aneurysm (AAA) to Monitor AAA Growth and Rupture Risk.

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Maria Sabater-Lleal, PhD; Phone Number: 8167 +34932919000; Email: msabater@santpau.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Recruiting
      • Hospital de la Santa Creu i Sant Pau
      • Contact: Maria Sabater-Lleal, PhD; Phone Number: 8167 +34932919000; Email: msabater@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

- Individuals with a diagnosis of AAA visiting at Hospital de Sant Pau or Hospital del Mar in Barcelona.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Aortic diameter	Diameter in mm	baseline, through study completion (every 2 years on average), pre-surgery

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Maria Sabater-Lleal, PhD, RESEARCH INSTITUTE/HOSP/SANTA CREU/PAU

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Aneurysm, Aorta, risk
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: IIBSP-OMI-2019-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No