CClinicalTrials.gg
CompletedNCT02913144Updated Sep 23, 2016

7 Year Follow-up Study of the DanRisk Population

An observational study in Cardiovascular Disease, Coronary Artery Calcification and Atherosclerosis, sponsored by Odense University Hospital. Completed. Open to participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Odense University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,257
Ages
55 Years to 65 Years
Sex
All
01

Study summary

OBJECTIVES: To investigate the incidence of cardiovascular events as well as progression of coronary artery calcium (CAC) in healthy middle-aged subjects over a period of 7 years, and the relation to traditional as well as new cardiovascular risk factors.

METHODS: The Danrisk cohort was established in 2009-2010 based on random retrieval from the Danish national civil registry (N=1825). Initially, distribution of gender, area of residence and year of birth (1949 or 1959) were equal among the 4 involved centres (OUH, Svendborg, Vejle and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to undergo cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for CAC estimation, and a total of 1227 subjects were found free of cardiovascular disease (CVD) and diabetes (DM), and was included in the study back then.

In 2014-2015 the DanRisk cohort was invited to a 5 year follow-up examination. The investigators examined a total of 1031 subjects (82%) in the investigators 4 regional centres. The follow-up examination included general health evaluation and estimation of CAC by non-contrast enhanced cardiac CT-scan. Information of death, cardiovascular events and medication usage was obtained from the Danish national patient register, the Danish register of causes of death and the Danish national database of reimbursed prescriptions in 2016.

02

Conditions studied

  • Cardiovascular Disease
  • Coronary Artery Calcification
  • Atherosclerosis
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 1,257 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The Danrisk cohort was established in 2009-2010 based on random retrieval from the Danish national civil registry (N=1825). Initially, distribution of gender, area of residence and year of birth (1949 or 1959) were equal among the 4 involved centres (OUH, Svendborg, Vejle and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to undergo cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for CAC estimation, and a total of 1227 subjects were found free of CVD and DM, and was included in the study back then.

In 2014-2015 the DanRisk cohort was invited to a 5 year re-examination. The investigators examined a total of 1031 subjects (82%) in the investigators 4 regional centres.

Inclusion criteria

  • Born in either 1949 or 1959
  • Residence in/near one of the regional centres (Esbjerg, Svendborg, Vejle, Odense).

Exclusion criteria

Exclusion Criteria:

  • Known cardiovascular disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,257 participants (actual)
Target follow-up
7 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Incident CV event

    Time frame: 6.5 years

Secondary outcomes

  1. CAC Progression

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02913144
Lead sponsor
Odense University Hospital
Responsible party
Mette Hjortdal Grønhøj (M.D, Odense University Hospital) — Principal investigator
First posted
Sep 23, 2016
Start date
May 2014
Primary completion
Jun 2015
Completion
Jun 2016
Last update
Sep 23, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion