Aortic Aneurysm, AbdominalNCT03616613
Aortic Abdominal Aneurysm Pilot Screening Programme
An observational study of Aortic Aneurysm, Abdominal, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in health areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Descriptive data analysis and cost-effectiveness study will be performed. Read more about this study
- Who is it for?
- Ages 65 to 65 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- ABDOMINAL DUPLEX ULTRASONOGRAPHY
- How many people
- 2,194 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jun 2018
- Phase
- Observational
- 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 65 to 65 years
- All sexes
- Older adult
Study population: All men and a random sample of women born in 1952 in Barcelona in the area that depends from Hospital de la Santa Creu i Sant Pau.
Who may be able to join
- All men in our area's population census and an aleatory sample of women born in 1952 living in Hospital de la Santa Creu i Sant Pau area.
Who cannot join
- Previously detected or operated AAA
- Fragile patients not eligible for AAA repair if needed
- Dead people when contacted
- Eligible people refusing to participate
- Eligible people failed to be contacted twice by our department
About this study
Official title: Analysis of Aortic Abdominal Aneurysm Prevalence in a Population Pilot Screening Program Based on Primary Care Duplex Ultrasound Evaluation
Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in health areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Descriptive data analysis and cost-effectiveness study will be performed.
Read the detailed description
Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Ultrasonography evaluations will be performed in primary health centers by previously trained doctors according to study protocol and AAA management will be according to United Kingdom's National Health Service screening model. A descriptive analysis will be performed to estimate local population prevalence of AAA in both men and women in order to create the basis for a future state AAA screening programme. A cost-effectiveness analysis will be performed in order to assess optimal screening strategies in our population.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- ABDOMINAL DUPLEX ULTRASONOGRAPHY
- 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.
ABDOMINAL DUPLEX ULTRASONOGRAPHYDiagnostic test
Abdominal ultrasonography performed by both primary care doctors or vascular surgeons in Hospital de la Santa Creu i Sant Pau area
| Study group | Role | What they receive |
|---|---|---|
| Men | Men born in 1952 in Barcelona in health areas depending from Hospital de la Santa Creu i Sant Pau. Receives: Diagnostic Test: ABDOMINAL DUPLEX ULTRASONOGRAPHY | |
| Women | Aleatory sample of women born in 1952 in Barcelona in health areas depending from Hospital de la Santa Creu i Sant Pau. Receives: Diagnostic Test: ABDOMINAL DUPLEX ULTRASONOGRAPHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal aortic measurement
Ultrasound infrarrenal aortic diameter measurement in mm
Measured: Days (only one day measurement is performed)
Secondary outcomes (11)
Smoking habits
Defined by current smoker, former smoker (more than one year without smoking) or non smoker
Measured: 1 day
Surgical intervention if needed
Registry of kind of intervention and date of intervention
Measured: 1 day
Family AAA history
First or second degree relatives with AAA, or no family AAA history
Measured: 1 day
Personal Cardiovascular Risk Factors
Coronary disease, neurovascular disease, peripheral arterial disease or diabetes mellitus
Measured: 1 day
Dislipidaemia
Altered lipid parameters in blood analysis
Measured: 1 day
Arterial Hypertension
Arterial hypertension under medical treatment
Measured: 1 day
Height
measures in cm
Measured: 1 day
Weight
measures in kg
Measured: 1 day
Abdominal perimeter
measures in cm
Measured: 1 day
Goldberg questionnaire
Complete goldberg anxiety and depression questionnaire. It consists of 12 questions and 5 posible answers for each question, and each answer is rated with 1 to 5 points. Total score above 9 indicates risk of depression.
Measured: 1 day
EuroQOL 5 score
EuroQOL 5 quality of life evaluation questionnaire. It consistis of 5 questions with 3 posible answers for each question, and a visual analogical scale for self health perception. Each combination of answers indicates a pattern of health status that can be rated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616613
- Sponsor's protocol ID
- IIBSP-AAA-2017-42
- Status last verified
- Aug 2018
- First submitted
- 14 Jun 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Aortic Abdominal Aneurysm Prevalence in a Population Pilot Screening Program Based on Primary Care Duplex Ultrasound Evaluation
- ClinicalTrials.gov ID
- NCT03616613
- Acronym / sponsor ID
- IIBSP-AAA-2017-42
- Conditions
- Aortic Aneurysm, Abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,194 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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.
Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in health areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Descriptive data analysis and cost-effectiveness study will be performed.
Detailed description
Populational abdominal aortic aneurysm (AAA) pilot screening programme performed by duplex ultrasonography in population born in 1952 in areas depending from Hospital de la Santa Creu i Sant Pau in Barcelona. Ultrasonography evaluations will be performed in primary health centers by previously trained doctors according to study protocol and AAA management will be according to United Kingdom's National Health Service screening model. A descriptive analysis will be performed to estimate local population prevalence of AAA in both men and women in order to create the basis for a future state AAA screening programme. A cost-effectiveness analysis will be performed in order to assess optimal screening strategies in our population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | Diagnostic Test: ABDOMINAL DUPLEX ULTRASONOGRAPHYMen born in 1952 in Barcelona in health areas depending from Hospital de la Santa Creu i Sant Pau. |
| Women | – | Diagnostic Test: ABDOMINAL DUPLEX ULTRASONOGRAPHYAleatory sample of women born in 1952 in Barcelona in health areas depending from Hospital de la Santa Creu i Sant Pau. |
Who may qualify
- Ages
- 65 to 65 years
- Sex
- All
- Age groups
- Older adult
- Study population
- All men and a random sample of women born in 1952 in Barcelona in the area that depends from Hospital de la Santa Creu i Sant Pau.
Key inclusion criteria (1 listed)
- All men in our area's population census and an aleatory sample of women born in 1952 living in Hospital de la Santa Creu i Sant Pau area.
Key exclusion criteria (5 listed)
- Previously detected or operated AAA
- Fragile patients not eligible for AAA repair if needed
- Dead people when contacted
- Eligible people refusing to participate
- Eligible people failed to be contacted twice by our department
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 |
|---|---|---|
| ABDOMINAL DUPLEX ULTRASONOGRAPHYAbdominal ultrasonography performed by both primary care doctors or vascular surgeons in Hospital de la Santa Creu i Sant Pau area | Diagnostic test | Men, Women |
Primary outcome
Abdominal aortic measurement
Time frame: Days (only one day measurement is performed)
Ultrasound infrarrenal aortic diameter measurement in mm
11 secondary outcomes
Smoking habits
Time frame: 1 day
Surgical intervention if needed
Time frame: 1 day
Family AAA history
Time frame: 1 day
Personal Cardiovascular Risk Factors
Time frame: 1 day
Dislipidaemia
Time frame: 1 day
Arterial Hypertension
Time frame: 1 day
Height
Time frame: 1 day
Weight
Time frame: 1 day
Abdominal perimeter
Time frame: 1 day
Goldberg questionnaire
Time frame: 1 day
EuroQOL 5 score
Time frame: 1 day
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 Aug 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 1 inclusion and 5 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Abdominal aortic measurement (time frame: Days (only one day measurement is performed)). 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 Aug 2018.