Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography (ECO-AAA)
This study is currently recruiting participants.
Verified September 2012 by Consorci d'Atenció Primària de Salut de l'Eixample
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: September 5, 2012
Last verified: September 2012
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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: 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 ]
| Estimated Enrollment: | 106 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679288
Contacts
| Contact: Antoni Sisó Almirall, MD PhD | 0034932279924 | asiso@clinic.ub.es |
Locations
| Spain | |
| CAPSE | Recruiting |
| Barcelona, Spain, 08028 | |
| Contact: Antoni Sisó Almirall, MD PhD 0034932279924 asiso@clinic.ub.es | |
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: | September 5, 2012 |
| 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 Atherosclerosis Hypertension Arteriosclerosis |
Aortic Diseases Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 21, 2013