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

Abdominal Aortic Aneurysm Clinical Trial

— BarcelonAAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882634
• Other study ID #: CP041192
• Status: Completed
• Phase: Phase 0
• First received: June 18, 2013
• Last updated: November 5, 2014
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Consorci d'Atenció Primària de Salut de l'Eixample
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Ultrasound (Trademark:VScan; Manufacturer:General Electric)
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)

Locations

Country	Name	City	State
Spain	Primary Care Center Casanova	Barcelona	Catalonia
Spain	Primary Care Center Comte Borrell	Barcelona	Catalonia
Spain	Primary Care Center Les Corts	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Consorci d'Atenció Primària de Salut de l'Eixample	Medtronic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care		12 months	No
Secondary	Associated risk factors to abdominal aortic aneurysm		12 months	No