HypertensionECO-AAANCT01679288
Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography
A study testing Ultrasound (Trademark:VScan; Manufacturer:General Electrics) in people with Hypertension and Abdominal Aortic Aneurysm, run by Consorci d'Atenció Primària de Salut de l'Eixample at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Abdominal Aortic Aneurysm, Atheromatosis
- What is being tested?
- Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers
- Former smokers.
- Hypertensive patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
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.
Read the 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
- Conditions
- Hypertension, Abdominal Aortic Aneurysm, Atheromatosis
- Being tested
- Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
- Keywords
- Hand-Held ultrasonography, Abdominal Aortic Aneurysm, Abdominal Aortic Atherosclerosis, Cardiovascular risk, Primary Health Care
- Medical subject headings
- Hypertension, Aortic Aneurysm, Abdominal, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (Trademark:VScan; Manufacturer:General Electrics)Device
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 group | Role | What they receive |
|---|---|---|
| ultrasound arm | Experimental | 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). Receives: Device: Ultrasound (Trademark:VScan; Manufacturer:General Electrics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
Measured: 24 months
Secondary outcomes (1)
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'Eixample
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
- Investigators
- Antoni Sisó Almirall, MD PhD, Principal investigator, Consorci d'Atenció Primària de Salut de l'Eixample
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679288
- Sponsor's protocol ID
- ECO-AAA
- Other IDs
- ECO-AAA-CAPSE
- Acronym
- ECO-AAA
- Status last verified
- Oct 2014
- First submitted
- 26 Jun 2012
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.
- ClinicalTrials.gov ID
- NCT01679288
- Acronym / sponsor ID
- ECO-AAA / ECO-AAA
- Conditions
- Hypertension, Abdominal Aortic Aneurysm, Atheromatosis
- Keywords
- Hand-Held ultrasonography, Abdominal Aortic Aneurysm, Abdominal Aortic Atherosclerosis, Cardiovascular risk, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'EixampleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound arm | Experimental | 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smokers
- Former smokers.
- Hypertensive patients
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | ultrasound arm |
Primary outcome
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
Time frame: 24 months
1 secondary outcome
Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
- Research group's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Sisó Almirall, MD PhD principal investigator
Consorci d'Atenció Primària de Salut de l'Eixample
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound (Trademark:VScan; Manufacturer:General Electrics) in people with Hypertension and Abdominal Aortic Aneurysm, run by Consorci d'Atenció Primària de Salut de l'Eixample at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.