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OpenTrials
Completed

NCT Number: NCT01882634

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

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Primary Care Center Casanova, Barcelona, Catalonia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound (Trademark:VScan; Manufacturer:General Electric)

Device

Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm)

Primary outcomes

  1. The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care

    Time frame: 12 months

Secondary outcomes

  1. Associated risk factors to abdominal aortic aneurysm

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Other

Collaborators

  • Medtronic

Registry information

Acronym: BarcelonAAA

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2013
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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