NCT03946410

Brief Summary

This study attempts to reduce social inequality in cardiovascular health by performing an interventional screening trial on how best to decrease cardiovascular disease (CVD) among people with low social status.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38,000

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2017Aug 2027

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 27, 2018

Last Update Submit

February 22, 2025

Conditions

Keywords

screeningpreventioncardiovascularpublic healthcost effectiveness

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    Deaths of any cause

    5 years

Study Arms (2)

Screening

ACTIVE COMPARATOR

Invitation to cardiovascular screening

Diagnostic Test: Invitation to screening

Control

PLACEBO COMPARATOR

No invitation to cardiovascular screening

Diagnostic Test: Invitation to screening

Interventions

Invitation to CVD screening with non contrast CT scanning, ABI measurement and blood tests

ControlScreening

Eligibility Criteria

Age60 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 60-64 living in the municipalities of Funen, Silkeborg, Vejle and surrounding municipailties

You may not qualify if:

  • Men not aged 60-64
  • Men not living in the mentioned municipalities
  • Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Odense University Hospital

Odense, 5000, Denmark

Location

Region Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

Svendborg Sygehus

Svendborg, 5700, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Related Publications (2)

  • Lindholt JS, Mejldal A, Rasmussen LM, Lambrechtsen J, Steffensen FH, Frost L, Egstrup K, Urbonaviciene G, Busk M, Karon M, Diederichsen ACP. Outcomes of cardiovascular screening in men aged 60-64 years: the DANCAVAS II trial. Eur Heart J. 2025 Aug 30:ehaf704. doi: 10.1093/eurheartj/ehaf704. Online ahead of print.

  • Khurrami L, Moller JE, Lindholt JS, Urbonaviciene G, Steffensen FH, Lambrechtsen J, Karon M, Frost L, Busk M, Egstrup K, Fredgart MH, Diederichsen ACP. Cross-sectional study of aortic valve calcification and cardiovascular risk factors in older Danish men. Heart. 2021 Oct;107(19):1536-1543. doi: 10.1136/heartjnl-2021-319023. Epub 2021 Aug 10.

MeSH Terms

Conditions

Heart DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Jes S Lindholt, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Vascular Surgery

Study Record Dates

First Submitted

February 27, 2018

First Posted

May 10, 2019

Study Start

August 1, 2017

Primary Completion

August 1, 2020

Study Completion (Estimated)

August 1, 2027

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Not possible due to data are stored and analysed in the platform of Statistics Denmark

Locations