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

NCT ID: NCT01882634

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1010 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-10-31

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Ultrasound arm

Group Type: EXPERIMENTAL

Ultrasound (Trademark:VScan; Manufacturer:General Electric)

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Consorci d'Atenció Primària de Salut de l'Eixample

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antoni Siso Almirall

Head of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoni Sisó Almirall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE)

Daniel Cararach Salami, MD

Role: STUDY_CHAIR

General Practitioner. Primary Care Center Les Corts, Consorci d'Atenció Primària de Salut Eixample (CAPSE)

Alfonso Pérez Jiménez, MD

Role: STUDY_CHAIR

General Practitioner. Primary Care Center Casanova, Consorci d'Atenció Primària de Salut Eixample (CAPSE)

Marta Navarro González, MD

Role: STUDY_CHAIR

General Practitioner. Primary Care Center Comte Borrell, Consorci d'Atenció Primària de Salut Eixample (CAPSE)

Rosa Gilabert Solé, MD PhD

Role: STUDY_CHAIR

Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic

Concepció Bru Saumell, MD PhD

Role: STUDY_CHAIR

Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic

Vicenç Riambau Alonso, MD PhD

Role: STUDY_CHAIR

Chief of Vascular Surgery Division, Thorax Institute, Hospital Clinic

Laura Sebastián Montal, MD

Role: STUDY_CHAIR

General Manager in Consorci d'Atenció Primària de Salut Eixample (CAPSE)

Jaume Benavent Àreu, MD

Role: STUDY_CHAIR

Director d'Afers Assistencials. Catalan Institute of Health. Ministry of Health. Catalonia, Spain.

Belchin Kostov, MSc

Role: STUDY_CHAIR

Statistician. Transverse Group for Research in Primary Care, IDIBAPS.

Locations

Primary Care Center Les Corts

Barcelona, Catalonia, Spain

Primary Care Center Casanova

Barcelona, Catalonia, Spain

Primary Care Center Comte Borrell

Barcelona, Catalonia, Spain

Countries

Spain

Other Identifiers

CP041192

Identifier Type: -

Identifier Source: org_study_id