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

Consorci d'Atenció Primària de Salut de l'Eixample

Status and phase

Completed

Early Phase 1

Conditions

Abdominal Aortic Aneurysm

Treatments

Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01882634

CP041192

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,010 patients

Sex

Male

Ages

60+ years old

Volunteers

No 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.