title: The Danish Cardiovascular Screening Trial (DANCAVAS): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease.
  
  
  METHODS
  Population-based randomized clinically controlled screening trial.
  
  
  METHODS
  
  
  
  METHODS
  45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used.
  
  
  METHODS
  One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings.
  
  
  OBJECTIVE
  To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective.
  
  
  RESULTS
  Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome).
  
  
  METHODS
  Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group.
  
  
  METHODS
  Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014.
  
  
  RESULTS
  A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%.
  
  
  CONCLUSIONS
  The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN12157806 (21 March 2015).
authors.affiliation: Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Department of Cardiology, University Hospital Odense, Odense, Denmark. Axel.Diederichsen@rsyd.dk.
authors.forename: Axel Cosmus Pyndt
authors.initials: AC
authors.lastname: Diederichsen
authors.affiliation: Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Department of Clinical Biochemistry and Pharmacology, University Hospital Odense, Odense, Denmark. Lars.Melholt.Rasmussen@rsyd.dk.
authors.forename: Lars Melholt
authors.initials: LM
authors.lastname: Rasmussen
authors.affiliation: Department of Public Health and Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. rs@ph.au.dk.
authors.forename: Rikke
authors.initials: R
authors.lastname: Søgaard
authors.affiliation: Department of Cardiology, University Hospital Odense, Svendborg, Denmark. Jess.Lambrechtsen@rsyd.dk.
authors.forename: Jess
authors.initials: J
authors.lastname: Lambrechtsen
authors.affiliation: Department of Cardiology, Vejle Hospital, Vejle, Denmark. Flemming.Hald@rsyd.dk.
authors.forename: Flemming Hald
authors.initials: FH
authors.lastname: Steffensen
authors.affiliation: Department of Cardiology, Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark. Larfrost@rm.dk.
authors.forename: Lars
authors.initials: L
authors.lastname: Frost
authors.affiliation: Department of Cardiology, University Hospital Odense, Svendborg, Denmark. Kenneth.Egstrup@rsyd.dk.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Egstrup
authors.affiliation: Department of Cardiology, Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark. Grazina.Urbonaviciene@rm.dk.
authors.forename: Grazina
authors.initials: G
authors.lastname: Urbonaviciene
authors.affiliation: Department of Cardiology, Vejle Hospital, Vejle, Denmark. Martin.Busk@rsyd.dk.
authors.forename: Martin
authors.initials: M
authors.lastname: Busk
authors.affiliation: Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Department of Endocrinology, University Hospital Odense, Odense, Denmark. Michael.olsen@dadlnet.dk.
authors.forename: Michael Hecht
authors.initials: MH
authors.lastname: Olsen
authors.affiliation: Department of Cardiology, University Hospital Odense, Odense, Denmark. Hans.Mickley@rsyd.dk.
authors.forename: Hans
authors.initials: H
authors.lastname: Mickley
authors.affiliation: Institute of Pharmacology, University of Southern Denmark, Odense, Denmark. jhallas@health.sdu.dk.
authors.forename: Jesper
authors.initials: J
authors.lastname: Hallas
authors.affiliation: Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark. Jes.Sanddal.lindholt@rsyd.dk.
authors.forename: Jes Sanddal
authors.initials: JS
authors.lastname: Lindholt
mesh_terms: D000367:Age Factors; D000368:Aged; D000465:Algorithms; D055109:Ankle Brachial Index; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000097:blood / Q000175:diagnosis* / Q000191:economics / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control; D002784:Cholesterol / Q000097:blood; D002985:Clinical Protocols; D017023:Coronary Angiography; D003362:Cost-Benefit Analysis; D003718:Denmark / Q000453:epidemiology; D017048:Health Care Costs; D006339:Heart Rate; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000191:economics / Q000379:methods; D011237:Predictive Value of Tests; D011314:Preventive Health Services / Q000191:economics / Q000379:methods; D011379:Prognosis; D012042:Registries; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D013686:Telemetry; D013997:Time Factors; D014057:Tomography, X-Ray Computed
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D002784:Cholesterol