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

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.
 
ClinicalTrials.gov Identifier: NCT01679288
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date October 16, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography
Official Title  ICMJE Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
Brief Summary 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Hypertension
  • Abdominal Aortic Aneurysm
  • Atheromatosis
Intervention  ICMJE 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).
Study Arms  ICMJE 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).
Intervention: Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2012)
106
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Smokers
  • Former smokers.
  • Hypertensive patients
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679288
Other Study ID Numbers  ICMJE ECO-AAA
ECO-AAA-CAPSE ( Registry Identifier: ECO-AAA-CAPSE )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
Study Sponsor  ICMJE Consorci d'Atenció Primària de Salut de l'Eixample
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antoni Sisó Almirall, MD PhD Consorci d'Atenció Primària de Salut de l'Eixample
PRS Account Consorci d'Atenció Primària de Salut de l'Eixample
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP