Brief Title
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark
Official Title
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
All cause mortality
Secondary Outcome
Cardiovascular events
Condition
Abdominal Aortic Aneurysms
Intervention
Screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
Study Arms / Comparison Groups
1
Description: Invited to screening for hypertension, lower limb atherosclerosis and abdominal aortic aneurysm
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
40000
Start Date
September 2008
Completion Date
December 2023
Primary Completion Date
September 2018
Eligibility Criteria
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
Gender
Male
Ages
65 Years - 74 Years
Accepts Healthy Volunteers
No
Contacts
Jes S. Lindholt, M.D.,Ph.D., +45 89272447, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00662480
Organization ID
M-20080028
Study Sponsor
Central Jutland Regional Hospital
Collaborators
Aarhus University Hospital
Study Sponsor
Jes S. Lindholt, M.D.,Ph.D., Principal Investigator, Vascular Research Unit, Viborg Hospital
Verification Date
February 2009