7 Year Follow-up Study of the DanRisk Population

Completed

• Conditions: Cardiovascular Disease; Coronary Artery Calcification; Atherosclerosis

• Registration Number: NCT02913144
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1257

Inclusion Criteria

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

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Exclusion Criteria

• Known cardiovascular disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incident CV event	6.5 years

Secondary Outcome Measures

Name	Time	Method
CAC Progression	5 years