7 Year Follow-up Study of the DanRisk Population
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|ClinicalTrials.gov Identifier: NCT02913144|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
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.
|Condition or disease|
|Cardiovascular Disease Coronary Artery Calcification Atherosclerosis|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1257 participants|
|Target Follow-Up Duration:||7 Years|
|Official 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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2016|
- Incident CV event [ Time Frame: 6.5 years ]
- CAC Progression [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA