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

Primary Purpose

Hypertension, Abdominal Aortic Aneurysm, Atheromatosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
Sponsored by
Consorci d'Atenció Primària de Salut de l'Eixample
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypertension focused on measuring Hand-Held ultrasonography, Abdominal Aortic Aneurysm, Abdominal Aortic Atherosclerosis, Cardiovascular risk, Primary Health Care

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Smokers
  • Former smokers.
  • Hypertensive patients

Sites / Locations

  • CAPSE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasound arm

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2012
Last Updated
October 15, 2014
Sponsor
Consorci d'Atenció Primària de Salut de l'Eixample
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1. Study Identification

Unique Protocol Identification Number
NCT01679288
Brief Title
Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography
Acronym
ECO-AAA
Official Title
Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Consorci d'Atenció Primària de Salut de l'Eixample

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Abdominal Aortic Aneurysm, Atheromatosis
Keywords
Hand-Held ultrasonography, Abdominal Aortic Aneurysm, Abdominal Aortic Atherosclerosis, Cardiovascular risk, Primary Health Care

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound arm
Arm Type
Experimental
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).
Intervention Type
Device
Intervention Name(s)
Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
Intervention 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).
Primary Outcome Measure Information:
Title
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Smokers Former smokers. Hypertensive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Sisó Almirall, MD PhD
Organizational Affiliation
Consorci d'Atenció Primària de Salut de l'Eixample
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAPSE
City
Barcelona
ZIP/Postal Code
08028
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.idibaps.org/research/7001/transverse-group-for-research-in-primary-care
Description
Research group's website

Learn more about this trial

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

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