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

NCT01882634 | Completed Early Phase 1 DMC

• 1 other identifier: CP041192
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 3

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

• Associated risk factors to abdominal aortic aneurysm

  12 months

Study Arms (1)

Ultrasound arm

EXPERIMENTAL

Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric)

Interventions

Ultrasound (Trademark:VScan; Manufacturer:General Electric) 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)

Ultrasound arm

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 60 years or more
• Attending at primary health care center for any complaint

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci d'Atenció Primària de Salut de l'Eixample: lead
• Medtronic: collaborator

Study Sites (3)

Primary Care Center Les Corts

Barcelona, Catalonia, 08028, Spain

Location

Primary Care Center Casanova

Barcelona, Catalonia, 08036, Spain

Location

Primary Care Center Comte Borrell

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Antoni Sisó Almirall, MD PhD

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

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

ES (3)