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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric)

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.

• Study Type: Interventional
• Enrollment (Actual): 1010
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08028
      • Primary Care Center Les Corts
    • Barcelona, Catalonia, Spain, 08036
      • Primary Care Center Casanova
    • Barcelona, Catalonia, Spain, 08036
      • Primary Care Center Comte Borrell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Ultrasound arm

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Associated risk factors to abdominal aortic aneurysm	12 months

Collaborators and Investigators

• Sponsor: Consorci d'Atenció Primària de Salut de l'Eixample
• Collaborators: Medtronic
• Investigators: Principal Investigator: Antoni Sisó Almirall, MD PhD, Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE); Study Chair: Daniel Cararach Salami, MD, General Practitioner. Primary Care Center Les Corts, Consorci d'Atenció Primària de Salut Eixample (CAPSE); Study Chair: Alfonso Pérez Jiménez, MD, General Practitioner. Primary Care Center Casanova, Consorci d'Atenció Primària de Salut Eixample (CAPSE); Study Chair: Marta Navarro González, MD, General Practitioner. Primary Care Center Comte Borrell, Consorci d'Atenció Primària de Salut Eixample (CAPSE); Study Chair: Rosa Gilabert Solé, MD PhD, Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic; Study Chair: Concepció Bru Saumell, MD PhD, Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic; Study Chair: Vicenç Riambau Alonso, MD PhD, Chief of Vascular Surgery Division, Thorax Institute, Hospital Clinic; Study Chair: Laura Sebastián Montal, MD, General Manager in Consorci d'Atenció Primària de Salut Eixample (CAPSE); Study Chair: Jaume Benavent Àreu, MD, Director d'Afers Assistencials. Catalan Institute of Health. Ministry of Health. Catalonia, Spain.; Study Chair: Belchin Kostov, MSc, Statistician. Transverse Group for Research in Primary Care, IDIBAPS.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (ESTIMATE): June 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP041192