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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
  Purpose
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.

Condition Intervention
Hypertension Abdominal Aortic Aneurysm Atheromatosis Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.

Resource links provided by NLM:


Further study details as provided by Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample:

Primary Outcome Measures:
  • Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ]

Enrollment: 106
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smokers
  • Former smokers.
  • Hypertensive patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679288


Locations
Spain
CAPSE
Barcelona, Spain, 08028
Sponsors and Collaborators
Consorci d'Atenció Primària de Salut de l'Eixample
Investigators
Principal Investigator: Antoni Sisó Almirall, MD PhD Consorci d'Atenció Primària de Salut de l'Eixample
  More Information

Additional Information:
Responsible Party: Dr. Antoni Siso Almirall, MD PhD, Consorci d'Atenció Primària de Salut de l'Eixample
ClinicalTrials.gov Identifier: NCT01679288     History of Changes
Other Study ID Numbers: ECO-AAA
ECO-AAA-CAPSE ( Registry Identifier: ECO-AAA-CAPSE )
First Submitted: June 26, 2012
First Posted: September 6, 2012
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample:
Hand-Held ultrasonography
Abdominal Aortic Aneurysm
Abdominal Aortic Atherosclerosis
Cardiovascular risk
Primary Health Care

Additional relevant MeSH terms:
Aneurysm
Atherosclerosis
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aortic Diseases