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

Early Phase 1

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT01882634
• Lead Sponsor: Consorci d'Atenció Primària de Salut de l'Eixample

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1010

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Associated risk factors to abdominal aortic aneurysm	12 months

Trial Locations

Locations (3)

Primary Care Center Les Corts; 🇪🇸 Barcelona, Catalonia, Spain

Primary Care Center Casanova; 🇪🇸 Barcelona, Catalonia, Spain

Primary Care Center Comte Borrell; 🇪🇸 Barcelona, Catalonia, Spain