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Completed

NCT Number: NCT01679288

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

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.

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Key information

Conditions

Hypertension Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Atheromatosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CAPSE

Barcelona, 08028, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Smokers
  • Former smokers.
  • Hypertensive patients

Treatment and study plan

Ultrasound (Trademark:VScan; Manufacturer:General Electrics)

Device

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).

Primary outcomes

  1. Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.

    Time frame: 24 months

Secondary outcomes

  1. Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Other

Registry information

Official study title

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

Acronym: ECO-AAA

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 6, 2012
Registry last updated
Oct 16, 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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