Cardiovascular Disease Clinical Trial
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
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.
Status | Completed |
Enrollment | 1257 |
Est. completion date | June 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years to 65 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incident CV event | 6.5 years | No | |
Secondary | CAC Progression | 5 years | No |
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