Abdominal Aortic AneurysmsPhase 4NCT00662480
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark
A Phase 4 study testing Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm in people with Abdominal Aortic Aneurysms and Peripheral Arterial Disease, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
Well-documented health benefits may be achieved through prophylactic screening for cardiovascular disease. The advantages are fewer premature deaths and a reduction in the number of hospital admissions and amputations. Read more about this study
- Who is it for?
- Ages 65 to 74 years, men only
- Conditions the study is for
- Abdominal Aortic Aneurysms, Peripheral Arterial Disease, Hypertension
- What is being tested?
- Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to Dec 2023
- Phase
- Phase 4
- 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 74 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- men aged 65-74 years old living in the central region of Denmark
Who cannot join
- men not aged 65-74 years
- men aged 65-74 years old not living in the central region of Denmark
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Vascular Research Unit, Dept. of Vasc. Surgery, Viborg Hospital
Viborg, 8800
Jes S. Lindholt, M.D., Ph.D.
About this study
Well-documented health benefits may be achieved through prophylactic screening for cardiovascular disease. The advantages are fewer premature deaths and a reduction in the number of hospital admissions and amputations. Furthermore, hospitals will benefit from the derived reduction in the pressure on surgery and intensive care capacities at vascular surgery departments.
It therefore seems extremely relevant to offer joint screening for abdominal aortic aneurysm, peripheral arterial disease and hypertension, even if the benefit and costs of such a measure are not currently known.
Read more
Consequently, the primary objective of the study is to establish the effect and cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years in a randomised, clinically controlled study.
The project manager will train six nurses to measure ABI and perform ultrasound scans of the aorta. The nurses form three teams which will each be equipped with a portable Doppler, blood pressure cuff and portable ultrasound scanner. Each team will operate from the hospitals in the Region. Civil registration number (in Danish: CPR), name and address information will be supplied by the Clinical Epidemiological Department (CED), which will also perform the randomisation in groups of approx. 1,000 to avoid too long a period from data extraction to invitation. Half of the randomised subjects will be invited to participate in a circulation examination focused on PAD, AAA and hypertension, while the other half will be controls Men with positive findings are informed and proper preventive actions is taken. Annual controls are offered, and AAA exceeding 5.5 cm in diameter is offered operation.
The primary efficiency variables are death, cardiovascular death and AAA-death. The secondary efficiency variables are hospital services related to cardiovascular conditions and costs for such services in accordance with current DRG rates.
The entire population, the controls as well as the screening group, will be monitored for a period of 10 years. Information concerning deaths, including date of death, is obtained from the Civil Registration System, information on visits to outpatient clinics and hospital admissions caused by cardiovascular conditions including amputations is obtained from the National Patient Registry. From the Danish Causes of Death Registry information on cause of death is collected. The information is classified with regards to cause; AAA or cardiovascular. The cardiovascular interventions are identified in the vascular surgery database (Karbasen). Major follow-up is performed at 3, 5 and 10 years.
A steering and data validation group will be formed including the project manager and a representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon from each of the two affected departments in the region will participate.
Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular hospital service are compared for the two groups using Cox proportional hazards-regression analysis which facilitates description of the risk ratio. The cost-efficiency calculation will be adjusted for quality of life.
- Being tested
- Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
- Keywords
- population, screening, abdominal aortic aneurysms, peripheral arterial disease, hypertension, Prevention
- Medical subject headings
- Aortic Aneurysm, Abdominal, Peripheral Arterial Disease, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysmProcedure or surgery
Invited to vascular screening
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Invited to screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm Receives: Procedure: Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm |
| 2 | No intervention | Participants which are not offered vascular screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 3, 5, and 10 years
Secondary outcomes (1)
Cardiovascular events
Measured: 3,5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2018 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmsStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Jes S. Lindholt, M.D.,Ph.D., Principal investigator, Vascular Research Unit, Viborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662480
- Sponsor's protocol ID
- M-20080028
- Status last verified
- Feb 2009
- First submitted
- 15 Apr 2008
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen KL, Kavaliunaite E, Rasmussen LM, Hallas J, Diederichsen A, Steffensen FH, Busk M, Frost L, Urbonaviciene G, Lambrechtsen J, Egstrup K, Lindholt JS. The association between diabetes and abdominal aortic aneurysms in men: results of two Danish screening studies, a systematic review, and a meta-analysis of population-based screening studies. BMC Cardiovasc Disord. 2023 Mar 16;23(1):139. doi: 10.1186/s12872-023-03160-8.
PubMed 36927295Lindholt JS, Diederichsen AC, Rasmussen LM, Frost L, Steffensen FH, Lambrechtsen J, Urbonaviciene G, Busk M, Egstrup K, Kristensen KL, Behr Andersen C, Sogaard R. Survival, Prevalence, Progression and Repair of Abdominal Aortic Aneurysms: Results from Three Randomised Controlled Screening Trials Over Three Decades. Clin Epidemiol. 2020 Jan 23;12:95-103. doi: 10.2147/CLEP.S238502. eCollection 2020.
PubMed 32158272Lindholt JS, Kristensen KL, Burillo E, Martinez-Lopez D, Calvo C, Ros E, Martin-Ventura JL, Sala-Vila A. Arachidonic Acid, but Not Omega-3 Index, Relates to the Prevalence and Progression of Abdominal Aortic Aneurysm in a Population-Based Study of Danish Men. J Am Heart Assoc. 2018 Jan 26;7(3):e007790. doi: 10.1161/JAHA.117.007790.
PubMed 29374048Lindholt JS, Sogaard R. Population screening and intervention for vascular disease in Danish men (VIVA): a randomised controlled trial. Lancet. 2017 Nov 18;390(10109):2256-2265. doi: 10.1016/S0140-6736(17)32250-X. Epub 2017 Aug 28.
PubMed 28859943Grondal N, Sogaard R, Henneberg EW, Lindholt JS. The Viborg Vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol. Trials. 2010 May 27;11:67. doi: 10.1186/1745-6215-11-67.
PubMed 20507582
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark
- ClinicalTrials.gov ID
- NCT00662480
- Acronym / sponsor ID
- M-20080028
- Keywords
- population, screening, abdominal aortic aneurysms, peripheral arterial disease, hypertension, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2008
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Apr 2008 (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.
Well-documented health benefits may be achieved through prophylactic screening for cardiovascular disease. The advantages are fewer premature deaths and a reduction in the number of hospital admissions and amputations. Furthermore, hospitals will benefit from the derived reduction in the pressure on surgery and intensive care capacities at vascular surgery departments.
It therefore seems extremely relevant to offer joint screening for abdominal aortic aneurysm, peripheral arterial disease and hypertension, even if the benefit and costs of such a measure are not currently known.
Consequently, the primary objective of the study is to establish the effect and cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years in a randomised, clinically controlled study.
The project manager will train six nurses to measure ABI and perform ultrasound scans of the aorta. The nurses form three teams which will each be equipped with a portable Doppler, blood pressure cuff and portable ultrasound scanner. Each team will operate from the hospitals in the Region. Civil registration number (in Danish: CPR), name and address information will be supplied by the Clinical Epidemiological Department (CED), which will also perform the randomisation in groups of approx. 1,000 to avoid too long a period from data extraction to invitation. Half of the randomised subjects will be invited to participate in a circulation examination focused on PAD, AAA and hypertension, while the other half will be controls Men with positive findings are informed and proper preventive actions is taken. Annual controls are offered, and AAA exceeding 5.5 cm in diameter is offered operation.
The primary efficiency variables are death, cardiovascular death and AAA-death. The secondary efficiency variables are hospital services related to cardiovascular conditions and costs for such services in accordance with current DRG rates.
The entire population, the controls as well as the screening group, will be monitored for a period of 10 years. Information concerning deaths, including date of death, is obtained from the Civil Registration System, information on visits to outpatient clinics and hospital admissions caused by cardiovascular conditions including amputations is obtained from the National Patient Registry. From the Danish Causes of Death Registry information on cause of death is collected. The information is classified with regards to cause; AAA or cardiovascular. The cardiovascular interventions are identified in the vascular surgery database (Karbasen). Major follow-up is performed at 3, 5 and 10 years.
A steering and data validation group will be formed including the project manager and a representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon from each of the two affected departments in the region will participate.
Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular hospital service are compared for the two groups using Cox proportional hazards-regression analysis which facilitates description of the risk ratio. The cost-efficiency calculation will be adjusted for quality of life.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysmInvited to screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm |
| 2 | No intervention | –Participants which are not offered vascular screening |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- men aged 65-74 years old living in the central region of Denmark
Key exclusion criteria (2 listed)
- men not aged 65-74 years
- men aged 65-74 years old not living in the central region of Denmark
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 |
|---|---|---|
| Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysmInvited to vascular screening | Procedure or surgery | 1 |
Primary outcome
All cause mortality
Time frame: 3, 5, and 10 years
1 secondary outcome
Cardiovascular events
Time frame: 3,5 and 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Derived from this study: PubMed 36927295Larsen KL, Kavaliunaite E, Rasmussen LM, Hallas J, Diederichsen A, Steffensen FH, Busk M, Frost L, Urbonaviciene G, Lambrechtsen J, Egstrup K, Lindholt JS. The association between diabetes and abdominal aortic aneurysms in men: results of two Danish screening studies, a systematic review, and a meta-analysis of population-based screening studies. BMC Cardiovasc Disord. 2023 Mar 16;23(1):139. doi: 10.1186/s12872-023-03160-8.
- Derived from this study: PubMed 32158272Lindholt JS, Diederichsen AC, Rasmussen LM, Frost L, Steffensen FH, Lambrechtsen J, Urbonaviciene G, Busk M, Egstrup K, Kristensen KL, Behr Andersen C, Sogaard R. Survival, Prevalence, Progression and Repair of Abdominal Aortic Aneurysms: Results from Three Randomised Controlled Screening Trials Over Three Decades. Clin Epidemiol. 2020 Jan 23;12:95-103. doi: 10.2147/CLEP.S238502. eCollection 2020.
- Derived from this study: PubMed 29374048Lindholt JS, Kristensen KL, Burillo E, Martinez-Lopez D, Calvo C, Ros E, Martin-Ventura JL, Sala-Vila A. Arachidonic Acid, but Not Omega-3 Index, Relates to the Prevalence and Progression of Abdominal Aortic Aneurysm in a Population-Based Study of Danish Men. J Am Heart Assoc. 2018 Jan 26;7(3):e007790. doi: 10.1161/JAHA.117.007790.
- Derived from this study: PubMed 28859943Lindholt JS, Sogaard R. Population screening and intervention for vascular disease in Danish men (VIVA): a randomised controlled trial. Lancet. 2017 Nov 18;390(10109):2256-2265. doi: 10.1016/S0140-6736(17)32250-X. Epub 2017 Aug 28.
- Derived from this study: PubMed 20507582Grondal N, Sogaard R, Henneberg EW, Lindholt JS. The Viborg Vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol. Trials. 2010 May 27;11:67. doi: 10.1186/1745-6215-11-67.
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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.
Jes S. Lindholt, M.D.,Ph.D. principal investigator
Vascular Research Unit, Viborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm in people with Abdominal Aortic Aneurysms and Peripheral Arterial Disease, run by Central Jutland Regional Hospital at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Feb 2016. 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 Denmark. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jes S. Lindholt, M.D., Ph.D. (+45 89272447, Jes.S.Lindholt@Viborg.RM.DK), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 3, 5, and 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662480, which also lists 5 linked publications.
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 25 Feb 2016.