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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913144
Other study ID # 13/31879
Secondary ID
Status Completed
Phase N/A
First received July 19, 2016
Last updated September 22, 2016
Start date May 2014
Est. completion date June 2016

Study information

Verified date July 2016
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The National Committee on Health Research Ethics
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Outcome

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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