Clinical trial NCT01882634: Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
Official title: Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Consorci d'Atenció Primària de Salut de l'Eixample
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-06-20
Enrollment: 1010
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
timeFrame: 12 months
Secondary outcomes:
measure: Associated risk factors to abdominal aortic aneurysm
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Primary Care Center Les Corts
state: Catalonia
city: Barcelona
country: Spain
facility: Primary Care Center Casanova
state: Catalonia
city: Barcelona
country: Spain
facility: Primary Care Center Comte Borrell
state: Catalonia
Study officials:
affiliation: Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE)
name: Antoni Sisó Almirall, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Practitioner. Primary Care Center Les Corts, Consorci d'Atenció Primària de Salut Eixample (CAPSE)
name: Daniel Cararach Salami, MD
role: STUDY_CHAIR
affiliation: General Practitioner. Primary Care Center Casanova, Consorci d'Atenció Primària de Salut Eixample (CAPSE)
name: Alfonso Pérez Jiménez, MD
role: STUDY_CHAIR
affiliation: General Practitioner. Primary Care Center Comte Borrell, Consorci d'Atenció Primària de Salut Eixample (CAPSE)
name: Marta Navarro González, MD
role: STUDY_CHAIR
affiliation: Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic
name: Rosa Gilabert Solé, MD PhD
role: STUDY_CHAIR
affiliation: Radiologist. Senior Consultant. Department of Radiology, Hospital Clínic
name: Concepció Bru Saumell, MD PhD
role: STUDY_CHAIR
affiliation: Chief of Vascular Surgery Division, Thorax Institute, Hospital Clinic
name: Vicenç Riambau Alonso, MD PhD
role: STUDY_CHAIR
affiliation: General Manager in Consorci d'Atenció Primària de Salut Eixample (CAPSE)
name: Laura Sebastián Montal, MD
role: STUDY_CHAIR
affiliation: Director d'Afers Assistencials. Catalan Institute of Health. Ministry of Health. Catalonia, Spain.
name: Jaume Benavent Àreu, MD
role: STUDY_CHAIR
affiliation: Statistician. Transverse Group for Research in Primary Care, IDIBAPS.
name: Belchin Kostov, MSc
role: STUDY_CHAIR
References: