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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:
Consorci d'Atenció Primària de Salut de l'Eixample
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
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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: None (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 Dr. Antoni Siso Almirall, 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 ]
Secondary Outcome Measures:
- Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Smokers
- Former smokers.
- Hypertensive patients
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01679288
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:
| 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 ( Registry Identifier: ECO-AAA-CAPSE ) |
| Study First Received: | June 26, 2012 |
| Last Updated: | October 15, 2014 |
Keywords provided by Dr. Antoni Siso Almirall, 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 Atherosclerosis Aortic Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on September 21, 2017