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

Study Overview
=================
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.

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

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound arm<br> | Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric)<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated risk factors to abdominal aortic aneurysm |  | 12 months |