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
| Tracking Information | |||||
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| First Received Date ICMJE | June 26, 2012 | ||||
| Last Updated Date | September 5, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01679288 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE |
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| 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). |
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| Study Arm (s) | 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) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 106 | ||||
| Estimated Completion Date | June 2014 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Male | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01679288 | ||||
| Other Study ID Numbers ICMJE | ECO-AAA, ECO-AAA-CAPSE | ||||
| Has Data Monitoring Committee | Yes | ||||
| 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 |
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| Information Provided By | Consorci d'Atenció Primària de Salut de l'Eixample | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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