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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01882634
First Posted: June 20, 2013
Last Update Posted: November 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
  Purpose
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.

Condition Intervention Phase
Abdominal Aortic Aneurysm Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric) Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care

Resource links provided by NLM:


Further study details as provided by Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample:

Primary Outcome Measures:
  • The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Associated risk factors to abdominal aortic aneurysm [ Time Frame: 12 months ]

Enrollment: 1010
Study Start Date: June 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882634


Locations
Spain
Primary Care Center Les Corts
Barcelona, Catalonia, Spain, 08028
Primary Care Center Casanova
Barcelona, Catalonia, Spain, 08036
Primary Care Center Comte Borrell
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Consorci d'Atenció Primària de Salut de l'Eixample
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.
  More Information

Responsible Party: Dr. Antoni Siso Almirall, Head of Research, Consorci d'Atenció Primària de Salut de l'Eixample
ClinicalTrials.gov Identifier: NCT01882634     History of Changes
Other Study ID Numbers: CP041192
First Submitted: June 18, 2013
First Posted: June 20, 2013
Last Update Posted: November 6, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases