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OpenTrials
Completed

NCT Number: NCT02913144

7 Year Follow-up Study of the DanRisk Population

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known cardiovascular disease

Treatment and study plan

Primary outcomes

  1. Incident CV event

    Time frame: 6.5 years

Secondary outcomes

  1. CAC Progression

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Implication of a Coronary Calcium Screening Examination, Incidence of Cardiovascular Events and Progression of Coronary Artery Calcium Over up to 7 Year of Follow-up in a Danish Middle-aged General Population

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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