7 Year Follow-up Study of the DanRisk Population

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913144
• Other study ID #: 13/31879
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Calcinosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Calcification
• Coronary Artery Disease

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