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

NCT ID: NCT01679288

Last Updated: 2014-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

Conditions

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Hypertension Abdominal Aortic Aneurysm Atheromatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Ultrasound (Trademark:VScan; Manufacturer:General Electrics)

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Smokers
* Former smokers.
* Hypertensive patients
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Consorci d'Atenció Primària de Salut de l'Eixample

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antoni Siso Almirall

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antoni Sisó Almirall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Consorci d'Atenció Primària de Salut de l'Eixample

Locations

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CAPSE

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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ECO-AAA-CAPSE

Identifier Type: REGISTRY

Identifier Source: secondary_id

ECO-AAA

Identifier Type: -

Identifier Source: org_study_id

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