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Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography (ECO-AAA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679288
First Posted: September 6, 2012
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
June 26, 2012
September 6, 2012
October 16, 2014
January 2011
October 2011   (Final data collection date for primary outcome measure)
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT01679288 on ClinicalTrials.gov Archive Site
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography
Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
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.
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Hypertension
  • Abdominal Aortic Aneurysm
  • Atheromatosis
Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
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).
Experimental: ultrasound arm
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).
Intervention: Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Smokers
  • Former smokers.
  • Hypertensive patients
Sexes Eligible for Study: Male
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01679288
ECO-AAA
ECO-AAA-CAPSE ( Registry Identifier: ECO-AAA-CAPSE )
Yes
Not Provided
Not Provided
Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
Consorci d'Atenció Primària de Salut de l'Eixample
Not Provided
Principal Investigator: Antoni Sisó Almirall, MD PhD Consorci d'Atenció Primària de Salut de l'Eixample
Consorci d'Atenció Primària de Salut de l'Eixample
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP