The Viborg vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol

• Main Authors: Henneberg Eskild W, Søgaard Rikke, Grøndal Nikolaj, Lindholt Jes S
• Format: Article
• Language: English
• Published: BMC 2010-05-01
• Series: Trials
• Online Access: http://www.trialsjournal.com/content/11/1/67

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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%.</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>Major follow-up will be performed at 3, 5 and 10 years and final study result after 15 years.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00662480</p>