The Viborg Vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol.
BACKGROUND
Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have implemented permanent programs. Around 10% of men in this group have peripheral arterial disease (PAD) defined by an ankle brachial systolic blood pressure index (ABI) below 0.9 resulting in an increased mortality-rate of 25-30%. In addition well-documented health benefits may be achieved through primary prophylaxis by initiating systematic cholesterol-lowering, smoking cessation, low-dose acetylsalicylic acid (aspirins), exercise, a healthy diet and blood-pressure control altogether reducing the increased risks for cardiovascular disease by at least 20-25%. The benefits of combining screening for AAA and PAD seem evident; yet they remain to be established. The objective of this study is to assess the efficacy and the cost-effectiveness of a combined screening program for AAA, PAD and hypertension.


METHODS
The Viborg Vascular (VIVA) screening trial is a randomized, clinically controlled study designed to evaluate the benefits of vascular screening and modern vascular prophylaxis in a population of 50,000 men aged 65-74 years. Enrolment started October 2008 and is expected to stop in October 2010. The primary outcome is all-cause mortality. The secondary outcomes are cardiovascular mortality, AAA-related mortality, hospital services related to cardiovascular conditions, prevalence of AAA, PAD and potentially undiagnosed hypertension, health-related quality of life and cost effectiveness. Data analysis by intention to treat.


RESULTS
Major follow-up will be performed at 3, 5 and 10 years and final study result after 15 years.


BACKGROUND
ClinicalTrials.gov NCT00662480.
Grøndal
Nikolaj
N
Department of vascular surgery, Viborg Hospital, Denmark. nikolaj.groendal@viborg.rm.dk
Søgaard
Rikke
R
Henneberg
Eskild W
EW
Lindholt
Jes S
JS
D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis* / Q000191:economics / Q000401:mortality*; D003362:Cost-Benefit Analysis; D003718:Denmark / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000191:economics / Q000401:mortality; D008297:Male; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D009313:National Health Programs / Q000191:economics; D016491:Peripheral Vascular Diseases / Q000175:diagnosis* / Q000191:economics / Q000401:mortality*; D015995:Prevalence; D011795:Surveys and Questionnaires