Cardiovascular Diseases Clinical Trial
Official title:
Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study
A polygenic risk score (PRS) will be developed and implemented into the primary care digital
work-flow.
1000 study subjects with no known cardiovascular disease, diabetes or statin treatment and
with high PRS (men of 30-65, women of 40-70 years of age) will be recruited from amongst the
gene donors of Estonian Biobank (Estonian Genome Center at the University of Tartu).
Subjects will be randomised to proactive primary preventive intervention incorporating
provision of PRS information or usual care (opportunistic preventive strategy).
Subjects in intervention group will be actively contacted and invited to a general
practitioner (GP) based prevention intervention of total cardiovascular risk scoring and
guideline recommended preventive measures.
Subjects in control group will be observed for 12 month and then invited to a GP visit and
provided the same information and advice as the intervention group.
The impact of PRS on total 10 year cardiovascular disease (CVD) risk scoring will be
assessed, the change in total 10 year CVD risk during the intervention will be measured and
the difference in total 10 year CVD risk between the groups at month 12 will be reported.
Satisfaction of subjects and GPs with the intervention will also be assessed as well as
cost-effectiveness of the intervention.
A polygenic risk score (PRS) will be developed and implemented into the primary care digital
work-flow.
1000 study subjects with no known cardiovascular disease, diabetes or statin treatment and
with high PRS (men of 30-65, women of 40-70 years of age) will be recruited from amongst the
gene donors of Estonian Biobank (Estonian Genome Center at the University of Tartu).
Subjects will be randomised to proactive primary preventive intervention incorporating
provision of PRS information or usual care (opportunistic preventive strategy).
Subjects in intervention group will be actively contacted and invited to a GP based
prevention intervention of total cardiovascular risk scoring and guideline recommended
preventive measures.
Subjects in control group will be observed for 12 month and then invited to a GP visit and
provided the same information and advice as the intervention group.
The impact of PRS on total 10 year CVD risk scoring will be assessed, the change in total 10
year CVD risk during the intervention will be measured and the difference in total 10 year
CVD risk between the groups at month 12 will be reported. Satisfaction of subjects and GPs
with the intervention will also be assessed as well as cost-effectiveness of the
intervention.
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