Abdominal Aortic AneurysmEarly Phase 1BarcelonAAANCT01882634
Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
A Early Phase 1 study testing Ultrasound (Trademark:VScan; Manufacturer:General Electric) in people with Abdominal Aortic Aneurysm, run by Consorci d'Atenció Primària de Salut de l'Eixample at 3 sites in Spain.
Trial summary
To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ultrasound (Trademark:VScan; Manufacturer:General Electric)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 3 sitesSpain
- Study dates
- Jun 2013to Oct 2014
- Phase
- Early Phase 1
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 60 years or more
- Attending at primary health care center for any complaint
Who cannot join
- Subjects being hemodynamically unstable at presentation
- Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique
- Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Primary Care Center Les Corts
Barcelona, Catalonia, 08028
Primary Care Center Casanova
Barcelona, Catalonia, 08036
Primary Care Center Comte Borrell
Barcelona, Catalonia, 08036
About this study
To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.
Read the detailed description
Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ultrasound (Trademark:VScan; Manufacturer:General Electric)
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (Trademark:VScan; Manufacturer:General Electric)Device
Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), 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 | Not described Receives: Device: Ultrasound (Trademark:VScan; Manufacturer:General Electric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
Measured: 12 months
Secondary outcomes (1)
Associated risk factors to abdominal aortic aneurysm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'Eixample
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- 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, Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE)Daniel Cararach Salami, MD, Study chair, General Practitioner. Primary Care Center Les Corts, Consorci d'Atenció Primària de Salut Eixample (CAPSE)Alfonso Pérez Jiménez, MD, Study chair, General Practitioner. Primary Care Center Casanova, Consorci d'Atenció Primària de Salut Eixample (CAPSE)Marta Navarro González, MD, Study chair, General Practitioner. Primary Care Center Comte Borrell, Consorci d'Atenció Primària de Salut Eixample (CAPSE)Rosa Gilabert Solé, MD PhD, Study chair, Radiologist. Senior Consultant. Department of Radiology, Hospital ClínicConcepció Bru Saumell, MD PhD, Study chair, Radiologist. Senior Consultant. Department of Radiology, Hospital ClínicVicenç Riambau Alonso, MD PhD, Study chair, Chief of Vascular Surgery Division, Thorax Institute, Hospital ClinicLaura Sebastián Montal, MD, Study chair, General Manager in Consorci d'Atenció Primària de Salut Eixample (CAPSE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882634
- Sponsor's protocol ID
- CP041192
- Acronym
- BarcelonAAA
- Status last verified
- Nov 2014
- First submitted
- 18 Jun 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
- ClinicalTrials.gov ID
- NCT01882634
- Acronym / sponsor ID
- BarcelonAAA / CP041192
- Conditions
- Abdominal Aortic Aneurysm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'EixampleUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jun 2013 (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.
To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.
Detailed description
Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA.
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 Electric) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men 60 years or more
- Attending at primary health care center for any complaint
Key exclusion criteria (3 listed)
- Subjects being hemodynamically unstable at presentation
- Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique
- Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.
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 Electric)Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm) | Device | Ultrasound arm |
Primary outcome
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
Time frame: 12 months
1 secondary outcome
Associated risk factors to abdominal aortic aneurysm
Time frame: 12 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 6 Nov 2014.
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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
Head of Research - Consorci d'Atenció Primària de Salut Eixample (CAPSE)
Daniel Cararach Salami, MD study chair
General Practitioner. Primary Care Center Les Corts, Consorci d'Atenció Primària de Salut Eixample (CAPSE)
Alfonso Pérez Jiménez, MD study chair
General Practitioner. Primary Care Center Casanova, Consorci d'Atenció Primària de Salut Eixample (CAPSE)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultrasound (Trademark:VScan; Manufacturer:General Electric) in people with Abdominal Aortic Aneurysm, run by Consorci d'Atenció Primària de Salut de l'Eixample at 3 sites 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 2 inclusion and 3 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 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care (time frame: 12 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 6 Nov 2014.