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 Type
Interventional
Primary Outcome
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
Secondary Outcome
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
Condition
Hypertension
Intervention
Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
Study Arms / Comparison Groups
ultrasound arm
Description: 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
Antoni Sisó Almirall, MD PhD, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
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
Study Sponsor
Antoni Sisó Almirall, MD PhD, Principal Investigator, Consorci d'Atenció Primària de Salut de l'Eixample
Verification Date
October 2014