The Danish Cardiovascular Screening Trial (DANCAVAS)
| ISRCTN | ISRCTN12157806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12157806 |
| ClinicalTrials.gov number | NCT03946410 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/03/2015
- Registration date
- 21/03/2015
- Last edited
- 14/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
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
Contact information
Public
Department of Cardiothoracic and Vascular Surgery T
Odense
5000
Denmark
Study information
| Study design | Randomized, clinical controlled, interventional multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 years |
| Study 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(s) | Southern Denmark Region Committee on Biomedical Research Ethics (S-20140028) and the Data Protection Agency |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2014 |
| Overall study end date | 01/01/2026 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 74 Years |
| Sex | Male |
| Target number of participants | 45000 |
| Total final enrolment | 47322 |
| 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 exclusion criteria | 1. Women 2. Men younger than 65 years |
| Recruitment start date | 01/10/2014 |
| Recruitment end date | 01/05/2017 |
Locations
Countries of recruitment
- Denmark
Study participating centres
5000 Odense C
5000
Denmark
Vejle
7100
Denmark
Silkeborg
8600
Denmark
Sponsor information
Government
Damhaven 12
Vejle
7100
Denmark
"ROR" |
https://ror.org/0290a6k23 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/12/2015 | Yes | No | |
| Results article | results | 01/04/2020 | 06/11/2019 | Yes | No |
| Results article | results | 23/01/2020 | 12/03/2020 | Yes | No |
| Results article | baseline results | 27/03/2019 | 12/08/2021 | Yes | No |
| Results article | results | 10/08/2021 | 12/08/2021 | Yes | No |
| Statistical Analysis Plan | version 6.0 | 03/01/2022 | 04/01/2022 | No | No |
| Results article | 5-year follow-up | 27/08/2022 | 30/08/2022 | Yes | No |
| Results article | 5 year outcomes | 13/10/2022 | 17/01/2023 | Yes | No |
| Statistical Analysis Plan | version 7 | 17/01/2023 | 17/01/2023 | No | No |
| Other publications | Post hoc analyses | 13/05/2024 | 14/05/2024 | Yes | No |
Additional files
Editorial Notes
14/05/2024: Publication reference added.
17/01/2023: The following changes were made to the trial record:
1. The statistical analysis plan (v7) was uploaded as an additional file.
2. Publication reference added.
30/08/2022: Publication reference added.
04/01/2022: The statistical analysis plan (SAP) has been uploaded.
12/08/2021: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added from the reference.
3. The ClinicalTrials.gov number has been added from the reference.
12/03/2020: Publication reference added.
06/11/2019: Publication reference added.
08/12/2015: Publication reference added.
