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Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography (ECO-AAA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
ClinicalTrials.gov Identifier:
NCT01679288
First received: June 26, 2012
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA) and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general practitioner in Primary Health Care.


Condition Intervention
Hypertension
Abdominal Aortic Aneurysm
Atheromatosis
Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.

Resource links provided by NLM:


Further study details as provided by Consorci d'Atenció Primària de Salut de l'Eixample:

Primary Outcome Measures:
  • Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ultrasound arm
Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).
Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).

Detailed Description:

Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk factors: active smokers, former smokers, or hypertensive patients, attended in primary health care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit under supervision of experienced radiologists using an standard ultrasound equipment and hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and video recorded are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioner and radiologist. Kappa index is calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic regression analysis is used to determine the factors that influence the presence of AA-At

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smokers
  • Former smokers.
  • Hypertensive patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679288

Locations
Spain
CAPSE
Barcelona, Spain, 08028
Sponsors and Collaborators
Consorci d'Atenció Primària de Salut de l'Eixample
Investigators
Principal Investigator: Antoni Sisó Almirall, MD PhD Consorci d'Atenció Primària de Salut de l'Eixample
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Antoni Siso Almirall, MD PhD, Consorci d'Atenció Primària de Salut de l'Eixample
ClinicalTrials.gov Identifier: NCT01679288     History of Changes
Other Study ID Numbers: ECO-AAA, ECO-AAA-CAPSE
Study First Received: June 26, 2012
Last Updated: October 15, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Consorci d'Atenció Primària de Salut de l'Eixample:
Hand-Held ultrasonography
Abdominal Aortic Aneurysm
Abdominal Aortic Atherosclerosis
Cardiovascular risk
Primary Health Care

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Arteriosclerosis
Atherosclerosis
Hypertension
Aortic Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014