Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography

Not Applicable

Completed

• Conditions: Hypertension; Abdominal Aortic Aneurysm; Atheromatosis

• Registration Number: NCT01679288
• Lead Sponsor: Consorci d'Atenció Primària de Salut de l'Eixample

Brief Summary

The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA) and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general practitioner in Primary Health Care.

Detailed Description

Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk factors: active smokers, former smokers, or hypertensive patients, attended in primary health care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit under supervision of experienced radiologists using an standard ultrasound equipment and hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and video recorded are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioner and radiologist. Kappa index is calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic regression analysis is used to determine the factors that influence the presence of AA-At

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 106

Inclusion Criteria

• Smokers
• Former smokers.
• Hypertensive patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.	24 months

Secondary Outcome Measures

Name	Time	Method
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care	24 months

Trial Locations

Locations (1)

CAPSE; 🇪🇸 Barcelona, Spain