Clinical trial NCT04291157: Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk
Official title: Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Primary Prevention
Keywords: Polygenic risk score
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: North Estonia Regional Hospital
name: Tartu University Hospital
First posted: 2020-03-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Large simple randomized trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male 30-65 years or female 40-70 years
* No history of ischemic heart disease, stroke, TIA or PAD in electronic health record
* No cholesterol lowering treatment
* No history of diabetes
* High PRS of CVD
* No physical or mental conditions precluding informed consent or participation

Exclusion Criteria:

* History of ischemic heart disease, stroke, transitory ischemic attack (TIA) or peripheral artery disease (PAD) in electronic health record
* Cholesterol lowering treatment
* History of diabetes
* No consent to participate

Primary outcomes:
measure: Total 10 year cardiovascular disease (CVD) risk
timeFrame: 12 months
Secondary outcomes:
measure: Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy
timeFrame: 12 months
measure: Adherence to CVD prevention recommendations
timeFrame: 12 months
measure: Systolic blood pressure
timeFrame: 12 months
measure: Diastolic blood pressure
timeFrame: 12 months
measure: Total cholesterol
timeFrame: 12 months
measure: LDL cholesterol
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Smoking status
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Satisfaction of gene donors with intervention
timeFrame: 12 months
measure: Satisfaction of GPs with intervention
timeFrame: 12 months
measure: Cost-effectiveness of intervention
timeFrame: 12 months, modelled over lifetime
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: University of Tartu
name: Margus Viigimaa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: