Abdominal Aortic AneurysmNCT02086617
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
A study testing ultrasound of aorta in people with Abdominal Aortic Aneurysm, run by North Karelia Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- ultrasound of aorta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Mar 2014to May 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with coronary artery disease
Who cannot join
- Already diagnosed or treated abdominal aortic aneurysm
- Patient's denial to participate
- Malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population.
Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture.
Read more
Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent.
800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- ultrasound of aorta
- 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 of aortaOther
| Study group | Role | What they receive |
|---|---|---|
| ultrasound of aorta | Other | Not described Receives: Other: ultrasound of aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound
Measured: Upon screening (AAA-screening appointment, 10 minutes per patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 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
- Phase N/A
- Primary purpose
- Screening
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086617
- Sponsor's protocol ID
- AAA-CAD-04
- Status last verified
- Jun 2014
- First submitted
- 11 Mar 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02086617
- Acronym / sponsor ID
- AAA-CAD-04
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Mar 2014 (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 investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population.
Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture.
Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent.
800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.
Study design
- Primary purpose
- Screening
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound of aorta | Other | Other: ultrasound of aorta |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients with coronary artery disease
Key exclusion criteria (3 listed)
- Already diagnosed or treated abdominal aortic aneurysm
- Patient's denial to participate
- Malignant disease
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 of aorta | Other | ultrasound of aorta |
Primary outcome
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound
Time frame: Upon screening (AAA-screening appointment, 10 minutes per patient)
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 26 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 of aorta in people with Abdominal Aortic Aneurysm, run by North Karelia Central Hospital at 1 site in Finland.
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 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 26 Jun 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 Finland. 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?
Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound (time frame: Upon screening (AAA-screening appointment, 10 minutes per patient)). 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 26 Jun 2014.