Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark

NCT00662480 | Unknown Phase 4 DMC

• 1 other identifier: M-20080028
• Study Type: interventional
• Target: 40,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Abdominal Aortic Aneurysms; Peripheral Arterial Disease; Hypertension

Keywords

population; screening; abdominal aortic aneurysms; peripheral arterial disease; hypertension; Prevention

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  3, 5, and 10 years

Secondary Outcomes (1)

• Cardiovascular events

  3,5 and 10 years

Study Arms (2)

1

EXPERIMENTAL

Invited to screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm

Procedure: Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm

2

NO INTERVENTION

Participants which are not offered vascular screening

Interventions

Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm PROCEDURE

Invited to vascular screening

1

Eligibility Criteria

• Age: 65 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• men aged 65-74 years old living in the central region of Denmark

You may not qualify if:

• men not aged 65-74 years
• men aged 65-74 years old not living in the central region of Denmark

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Vascular Research Unit, Dept. of Vasc. Surgery, Viborg Hospital

Viborg, 8800, Denmark

RECRUITING

Related Publications (5)

• 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.

  PMID: 36927295 DERIVED

• Lindholt 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.

  PMID: 32158272 DERIVED

• Lindholt 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.

  PMID: 29374048 DERIVED

• Lindholt 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.

  PMID: 28859943 DERIVED

• Grondal 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.

  PMID: 20507582 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Peripheral Arterial Disease; Hypertension

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Jes S. Lindholt, M.D.,Ph.D.

  Vascular Research Unit, Viborg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jes S. Lindholt, M.D., Ph.D.

CONTACT

+45 89272447; Jes.S.Lindholt@Viborg.RM.DK

Eskild W. Henneberg, M.D.,

CONTACT

+45 89272445; Eskild.W.Henneberg@Viborg.RM.DK

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 21, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2023
• Last Updated: February 25, 2016

Record last verified: 2009-02

Locations

DK (1)