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.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00662480.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aortic Aneurysm, Abdominal / diagnosis*
  • Aortic Aneurysm, Abdominal / economics
  • Aortic Aneurysm, Abdominal / mortality*
  • Cost-Benefit Analysis
  • Denmark / epidemiology
  • Follow-Up Studies
  • Humans
  • Hypertension / diagnosis
  • Hypertension / economics
  • Hypertension / mortality
  • Male
  • Mass Screening / economics
  • Mass Screening / methods*
  • National Health Programs / economics
  • Peripheral Vascular Diseases / diagnosis*
  • Peripheral Vascular Diseases / economics
  • Peripheral Vascular Diseases / mortality*
  • Prevalence
  • Surveys and Questionnaires

Associated data

  • ClinicalTrials.gov/NCT00662480