Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography (ECO-AAA)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Abdominal Aortic Aneurysm; Atheromatosis	Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	106 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
Study Start Date :	January 2011
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Arms and Interventions

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Arm

Intervention/treatment

Experimental: ultrasound arm; Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).

Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics); Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).

Outcome Measures

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Primary Outcome Measures :

1. Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Smokers
• Former smokers.
• Hypertensive patients

Contacts and Locations

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Locations

Spain
CAPSE
Barcelona, Spain, 08028

Sponsors and Collaborators

Consorci d'Atenció Primària de Salut de l'Eixample

Investigators

Principal Investigator:	Antoni Sisó Almirall, MD PhD	Consorci d'Atenció Primària de Salut de l'Eixample

More Information

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Additional Information:

Institutional website 

Research group's website 

Responsible Party:	Dr. Antoni Siso Almirall, MD PhD, Consorci d'Atenció Primària de Salut de l'Eixample
ClinicalTrials.gov Identifier:	NCT01679288 History of Changes
Other Study ID Numbers:	ECO-AAA; ECO-AAA-CAPSE ( Registry Identifier: ECO-AAA-CAPSE )
First Posted:	September 6, 2012
Last Update Posted:	October 16, 2014
Last Verified:	October 2014

Keywords provided by Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample:

Hand-Held ultrasonography; Abdominal Aortic Aneurysm; Abdominal Aortic Atherosclerosis; Cardiovascular risk; Primary Health Care

Additional relevant MeSH terms:

Aneurysm; Atherosclerosis; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Diseases