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Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk

NCT04291157 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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

Total CVD risk estimation using SCORE plus PRS and European Society of Cardiology (ESC) CVD prevention guideline based interventions.

OTHER

Standard GP care

Usual GP care (opportunistic CVD prevention)

Sponsors & Collaborators

  • North Estonia Regional Hospital

    collaborator UNKNOWN

  • Tartu University Hospital

    collaborator OTHER

  • Alar Irs

    lead OTHER

Principal Investigators

  • Margus Viigimaa, MD, PhD · University of Tartu

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • Estonia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291157 on ClinicalTrials.gov