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NCT01679288 Clinical Trial

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

Hypertension Clinical Trial

— ECO-AAA  

Official title:
Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01679288
Other study ID # ECO-AAA
Secondary ID ECO-AAA-CAPSE
Status Completed
Phase N/A
First received June 26, 2012
Last updated October 15, 2014
Start date January 2011
Est. completion date October 2011

Study information
Verified date October 2014
Source Consorci d'Atenció Primària de Salut de l'Eixample
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Smokers

- Former smokers.

- Hypertensive patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Spain CAPSE Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Consorci d'Atenció Primària de Salut de l'Eixample

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. 24 months No
Secondary Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care 24 months No
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