Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care

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Disease Information

Descriptive Information
Brief Title † Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
Official Title † Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
Brief Summary To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.
Detailed Description Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA.
Study Phase Phase 0
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Primary Outcome Measure † The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
Secondary Outcome Measure † Associated risk factors to abdominal aortic aneurysm
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceUltrasound (Trademark:VScan; Manufacturer:General Electric)
Study Arms / Comparison Groups Ultrasound arm
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 † 1010
Start Date † June 2013
Completion Date October 2014
Primary Completion Date October 2014
Eligibility Criteria † Inclusion Criteria: - Men 60 years or more - Attending at primary health care center for any complaint Exclusion Criteria: - Subjects being hemodynamically unstable at presentation - Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique - Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.
Gender Male
Ages 60 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Spain
Administrative Information
NCT ID † NCT01882634
Organization ID CP041192
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Consorci d'Atenció Primària de Salut de l'Eixample
Collaborators †† Medtronic
Investigators † Principal Investigator: Antoni Sisó Almirall, MD PhD, Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE)
Information Provided By
Verification Date November 2014
First Received Date † June 18, 2013
Last Updated Date November 5, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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