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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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