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

Early Phase 1CompletedNCT01882634

Consorci d'Atenció Primària de Salut de l'Eixample1,010 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,010

Conditions

Abdominal Aortic Aneurysm

Interventions

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

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)

Eligibility

Sex: MALEMin age: 60 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care

Time frame: 12 months

Secondary Outcomes

Associated risk factors to abdominal aortic aneurysm

Time frame: 12 months

Data from ClinicalTrials.gov

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