Condition category
Circulatory System
Date applied
11/03/2015
Date assigned
21/03/2015
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The significant increase in the average lifespan has resulted in an increase in medical and community resources needed to manage serious age-related diseases, such as cancer and cardiovascular disease (for example, heart disease and stroke). Routine medical checks by general practitioners are often not sufficient to identify a person developing cardiovascular disease. In this study, we aim to
investigate whether advanced cardiovascular screenings will prevent cardiovascular events (such as a heart attack) , and whether the possible health benefits are cost effective.

Who can participate?
Danish men aged between 65-74 years living in the Island of Fyn, and the communities of Vejle and Silkeborg in Denmark

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are invited to attend an advanced cardiovascular screening examination. The screening includes detecting coronary artery disease and aneurysms (via the use of CT scans), blood pressure tests, tests to check heart rhythm and tests to check for high cholesterol levels and diabetes. Biological samples will be performed for biomarker and translational research. Participants in group 2 (control) receive their usual medical care and are not offered an advanced cardiovascular screening examination.

What are the possible benefits and risks of participating?
For participants in group 1 found to be developing cardiovascular disease, preventive actions, including medical treatment and possibly surgery, will be taken.

Where is the study run from?
Four hospital sites in the Island of Fyn, Vejle and Silkeborg (Denmark)

When is the study starting and how long is it expected to run for?
January 2014 to January 2026

Who is funding the study?
Region of Southern Denmark Research Group

Who is the main contact?
Professor Jes Lindholt

Trial website

Contact information

Type

Public

Primary contact

Dr Jes Lindholt

ORCID ID

Contact details

Department of Cardiothoracic and Vascular Surgery T
Odense
5000
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Danish Cardiovascular Screening Trial (DANCAVAS): a large population-based randomized clinical multicenter trial testing combo cardiovascular screening in men aged 65-74 year old

Acronym

DANCAVAS

Study hypothesis

The primary hypothesis is that the offer of an extensive circulatory screening and intervention programme fulfills the WHO criteria for screening especially concerning the significance of the diseases, the treatment benefits, and the cost effectiveness.

Ethics approval

Southern Denmark Region Committee on Biomedical Research Ethics (S-20140028) and the Data Protection Agency

Study design

Randomised, clinical controlled, interventional multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Cardiovascular disease

Intervention

Half of the study participants are randomised to the usual care without any screening (control group), while the other half of participants are invited to a screening and intervention programme that measures traditional risk factors, CAC, aneurysms, and PAD (screening group) and offer general cardiovascular prevention in case of positive finding.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

All cause mortality

Secondary outcome measures

1. Costs and cost effectiveness after 3, 5 and 10 years to assess possible health and/or societal benefits of the screening.
2. Nationwide registry based information on health care consumption including contacts to GP and use of drugs, as well as hospital submissions.

Overall trial start date

01/01/2014

Overall trial end date

01/01/2026

Reason abandoned

Eligibility

Participant inclusion criteria

Danish men aged 65-74 years old living in the Island of Fyn, and the communities of Vejle and Silkeborg in Denmark.

Participant type

All

Age group

Senior

Gender

Male

Target number of participants

45000

Participant exclusion criteria

1. Women
2. Men younger than 65

Recruitment start date

01/10/2014

Recruitment end date

01/05/2017

Locations

Countries of recruitment

Denmark

Trial participating centre

Odense University Hospital
Sdr. Boulevard 29 5000 Odense C
5000
Denmark

Trial participating centre

Vejle Sygehus
Kabbeltoft 25
Vejle
7100
Denmark

Trial participating centre

Regionshospitalet Silkeborg
Falkevej 3
Silkeborg
8600
Denmark

Sponsor information

Organisation

The Region of Southern Denmark

Sponsor details

Damhaven 12
Vejle
7100
Denmark

Sponsor type

Government

Website

Funders

Funder type

Not defined

Funder name

Region of Southern Denmark Research Group (Region Syddanmarks Forskningspulje (Denmark))

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The entire study population, the controls as well as the screening group, will be monitored for a period of 10 years. The primary efficiency variable is overall mortality, while hospitalisations and deaths from cardiovascular diseases (cerebrovascular, cardiac, aneurysm, or other vascular) are the secondary variables. These endpoints are compared for the two groups using a Cox proportional hazards-regression analysis. The cost-efficiency calculation will be adjusted for the quality of life.
An independent endpoint committee will review registry data on the causes of death and data from the Danish National Patient Register concerning hospital admissions; supplemental data will be requested from hospitals and the GP if needed. The health economics of the screening program will be evaluated with two types of analyses. A trial-based evaluation will be conducted after 5 and 10 years of follow-up, whereas the lifetime perspective on the health economics of the screening will be evaluated in a separate decision analytic model for the men and women. First major publication date is planned for 1st of July 2018

Intention to publish date

01/07/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26637993

Publication citations

Additional files

Editorial Notes

08/12/2015: Publication reference added.