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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
Sponsor:
Information provided by (Responsible Party):
Mette Hjortdal Grønhøj, 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.


Condition or disease
Cardiovascular Disease Coronary Artery Calcification Atherosclerosis

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1257 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Incident CV event [ Time Frame: 6.5 years ]

Secondary Outcome Measures :
  1. CAC Progression [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
a biobank consisting of plasma and serum was established in 2009 and also in 2014-15.


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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 CVD and DM, and was included in the study back then.

In 2014-2015 the DanRisk cohort was invited to a 5 year re-examination. The investigators examined a total of 1031 subjects (82%) in the investigators 4 regional centres.

Criteria

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
Additional Information:

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Responsible Party: Mette Hjortdal Grønhøj, M.D, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02913144    
Other Study ID Numbers: 13/31879
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases