Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk (EstPerMedCV)

Alar Irs

Status: Unknown

Conditions: Primary Prevention; Cardiovascular Diseases

Treatments: Other: Standard GP care; Other: CVD risk estimation incorporating the PRS and guideline based preventive interventions.

Study type: Interventional

Funder types: Other

Identifiers

NCT04291157

EstPerMed CV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Proactive CVD prevention

Experimental group

Description:

Proactive invitation to total CVD risk estimation incorporating the PRS and provision of guideline based preventive interventions.

Treatment:

Other: CVD risk estimation incorporating the PRS and guideline based preventive interventions.

Usual care

Active Comparator group

Description:

Usual GP care (opportunistic CVD risk estimation and prevention upon usual GP contacts).

Treatment:

Other: Standard GP care