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

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Disease Information

Descriptive Information
Brief Title † Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography
Official Title † Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
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 Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Primary Outcome Measure † Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
Secondary Outcome Measure † Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
Condition † Hypertension Abdominal Aortic Aneurysm Atheromatosis
Intervention † DeviceUltrasound (Trademark:VScan; Manufacturer:General Electrics)
Study Arms / Comparison Groups 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).
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 106
Start Date † January 2011
Completion Date October 2011
Primary Completion Date October 2011
Eligibility Criteria † Inclusion Criteria: - Smokers - Former smokers. - Hypertensive patients
Gender Male
Ages 50 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † Spain
Administrative Information
NCT ID † NCT01679288
Organization ID ECO-AAA
Secondary IDs †† ECO-AAA-CAPSE
Responsible Party Principal Investigator
Study Sponsor † Consorci d'Atenció Primària de Salut de l'Eixample
Collaborators ††
Investigators † Principal Investigator: Antoni Sisó Almirall, MD PhD, Consorci d'Atenció Primària de Salut de l'Eixample
Information Provided By
Verification Date October 2014
First Received Date † June 26, 2012
Last Updated Date October 15, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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