Abdominal Aortic AneurysmCAD-AAANCT01897623
Prevalence and 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 the prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD) verified in coronary angiography. Read more about this study
- Who is it for?
- Any age, 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
- Jul 2013to Oct 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 Any age
- Men only
- Child, Adult, Older adult
Who may be able to join
- Male patients with coronary artery disease
Who cannot join
- Patient's denial to participate
- Female Gender
- Already diagnosed or treated abdominal aortic aneurysm
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD) verified in coronary angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these CAD patients, thus making screening of these patients (for AAA) more cost-efficient.
Study will be carried out as a multi-center prospective screening study. Data will be collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere University Hospital. Data consists of 200 consecutive coronary angiography patients in each hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with previously known AAA will be excluded from the study.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 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
- Phase N/A
- Primary purpose
- Screening
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, Tampere University Hospital
- Responsible party
- Principal investigator, Ville Vänni, North Karelia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897623
- Sponsor's protocol ID
- AAA-CAD-02
- Acronym
- CAD-AAA
- Status last verified
- Dec 2014
- First submitted
- 9 Jul 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01897623
- Acronym / sponsor ID
- CAD-AAA / AAA-CAD-02
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, Tampere University Hospital
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Jul 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.
The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD) verified in coronary angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these CAD patients, thus making screening of these patients (for AAA) more cost-efficient.
Study will be carried out as a multi-center prospective screening study. Data will be collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere University Hospital. Data consists of 200 consecutive coronary angiography patients in each hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with previously known AAA will be excluded from the study.
Study design
- Primary purpose
- Screening
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound of aorta | Other | Other: ultrasound of aorta |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients with coronary artery disease
Key exclusion criteria (3 listed)
- Patient's denial to participate
- Female Gender
- Already diagnosed or treated abdominal aortic aneurysm
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
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 17 Dec 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 17 Dec 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). 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 17 Dec 2014.