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Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care (BarcelonAAA)

Primary Purpose

Abdominal Aortic Aneurysm

Status

Completed

Phase

Early Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Ultrasound (Trademark:VScan; Manufacturer:General Electric)

About this trial

This is an interventional screening trial for Abdominal Aortic Aneurysm

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Men 60 years or more
Attending at primary health care center for any complaint

Exclusion Criteria:

Subjects being hemodynamically unstable at presentation
Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique
Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.

Sites / Locations

Primary Care Center Les Corts
Primary Care Center Casanova
Primary Care Center Comte Borrell

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound arm

Arm Description

Outcomes

Primary Outcome Measures

The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care

Secondary Outcome Measures

Associated risk factors to abdominal aortic aneurysm

Full Information

NCT ID

NCT01882634

First Posted

June 18, 2013

Last Updated

November 5, 2014

Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01882634

Brief Title

Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care

Acronym

BarcelonAAA

Official Title

Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.

Detailed Description

Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose

Screening

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1010 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound arm

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Ultrasound (Trademark:VScan; Manufacturer:General Electric)

Intervention Description

Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm)

Primary Outcome Measure Information:

Title

The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Associated risk factors to abdominal aortic aneurysm

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men 60 years or more Attending at primary health care center for any complaint Exclusion Criteria: Subjects being hemodynamically unstable at presentation Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.

Overall Study Officials: