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

This study is currently recruiting participants.
Verified February 2009 by Viborg Hospital
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
Viborg Hospital
ClinicalTrials.gov Identifier:
NCT00662480
First received: April 15, 2008
Last updated: January 13, 2010
Last verified: February 2009

April 15, 2008
January 13, 2010
September 2008
September 2018   (final data collection date for primary outcome measure)
All cause mortality [ Time Frame: 3, 5, and 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662480 on ClinicalTrials.gov Archive Site
Cardiovascular events [ Time Frame: 3,5 and 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
  • Prevention
  • Screening
  • Abdominal Aortic Aneurysms
  • Peripheral Arterial Disease
  • Hypertension
Procedure: Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
Invited to vascular screening
  • Experimental: 1
    Invited to screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
    Intervention: Procedure: Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
  • No Intervention: 2
    Participants which are not offered vascular screening
Grøndal N, Søgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40000
December 2023
September 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • men not aged 65-74 years
  • men aged 65-74 years old not living in the central region of Denmark
Male
65 Years to 74 Years
No
Contact: Jes S. Lindholt, M.D., Ph.D. +45 89272447 Jes.S.Lindholt@Viborg.RM.DK
Contact: Eskild W. Henneberg, M.D., +45 89272445 Eskild.W.Henneberg@Viborg.RM.DK
Denmark
 
NCT00662480
M-20080028
Yes
Jes S. Lindholt, Vascular Research Unit, Department of Vascular Surgery, Viborg Hospital
Viborg Hospital
Aarhus University Hospital
Principal Investigator: Jes S. Lindholt, M.D.,Ph.D. Vascular Research Unit, Viborg Hospital
Viborg Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP