Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01882634

Acronym

BarcelonAAA

Enrollment

1010

Registered

2013-06-20

Start date

2013-06-30

Completion date

2014-10-31

Last updated

2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Brief summary

To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.

Detailed description

Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA.

Interventions

DEVICEUltrasound (Trademark:VScan; Manufacturer:General Electric)

Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men 60 years or more * Attending at primary health care center for any complaint

Exclusion criteria

* Subjects being hemodynamically unstable at presentation * Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique * Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.

Design outcomes

Primary

Measure	Time frame
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care	12 months

Secondary

Measure	Time frame
Associated risk factors to abdominal aortic aneurysm	12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026