Abdominal Aortic AneurysmTABSNCT06827652
Triple-A Barcelona Study
An observational study of Abdominal Aortic Aneurysm, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2020to 31 Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Individuals with a diagnosis of AAA visiting at Hospital de Sant Pau or Hospital del Mar in Barcelona.
Who may be able to join
- clinical diagnosis of abdominal aortic aneurysm
- infrarenal abdominal aortic diameter greater than 30 mm
Who cannot join
- Type B dissections that progress to AAA
- saccular aneurysms
- mycotic aneurysms
- visceral aneurysms
- thoracic aneurysms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Maria Sabater-Lleal, PhD, +34932919000 ext. 8167, msabater@santpau.cat
About this study
Official title: 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.
Read the 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
- Keywords
- Aneurysm, Aorta, risk
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Aortic diameter
Diameter in mm
Measured: baseline, through study completion (every 2 years on average), pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start5 Oct 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Sabater-Lleal, PhD, Principal investigator, RESEARCH INSTITUTE/HOSP/SANTA CREU/PAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827652
- Sponsor's protocol ID
- IIBSP-OMI-2019-102
- Acronym
- TABS
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study of Individuals with Abdominal Aortic Aneurysm (AAA) to Monitor AAA Growth and Rupture Risk.
- ClinicalTrials.gov ID
- NCT06827652
- Acronym / sponsor ID
- TABS / IIBSP-OMI-2019-102
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Aneurysm, Aorta, risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Feb 2025 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Individuals with a diagnosis of AAA visiting at Hospital de Sant Pau or Hospital del Mar in Barcelona.
Key inclusion criteria (2 listed)
- clinical diagnosis of abdominal aortic aneurysm
- infrarenal abdominal aortic diameter greater than 30 mm
Key exclusion criteria (5 listed)
- Type B dissections that progress to AAA
- saccular aneurysms
- mycotic aneurysms
- visceral aneurysms
- thoracic aneurysms.
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
Abdominal Aortic diameter
Time frame: baseline, through study completion (every 2 years on average), pre-surgery
Diameter in mm
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 14 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Maria Sabater-Lleal, PhD principal investigator
RESEARCH INSTITUTE/HOSP/SANTA CREU/PAU
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 Abdominal Aortic Aneurysm, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 5 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 14 Feb 2025. 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 Spain. 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 Maria Sabater-Lleal, PhD (+34932919000 ext. 8167, msabater@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Aortic diameter (time frame: baseline, through study completion (every 2 years on average), pre-surgery). 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 14 Feb 2025.