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Clinical Trials/NCT01882634
NCT01882634
Completed
Early Phase 1

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

Consorci d'Atenció Primària de Salut de l'Eixample3 sites in 1 country1,010 target enrollmentJune 2013

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysm
Sponsor
Consorci d'Atenció Primària de Salut de l'Eixample
Enrollment
1010
Locations
3
Primary Endpoint
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Consorci d'Atenció Primària de Salut de l'Eixample
Responsible Party
Principal Investigator
Principal Investigator

Dr. Antoni Siso Almirall

Head of Research

Consorci d'Atenció Primària de Salut de l'Eixample

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

  • Associated risk factors to abdominal aortic aneurysm(12 months)

Study Sites (3)

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