Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk

NCT04291157 | Unknown

• 1 other identifier: EstPerMed CV
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Primary Prevention

Keywords

Polygenic risk score

Outcome Measures

Primary Outcomes (1)

• Total 10 year cardiovascular disease (CVD) risk

  SCORE (Systematic COronary Risk Evaluation), estimates fatal cardiovascular disease events over a ten-year period in %. Employs categories of 1) low (calculated SCORE \<1%) 2) moderate-risk (calculated SCORE1% to \<5%), 39 ) high-risk (calculated SCORE5% to \<10%) and 3) very-high-risk (calculated SCORE ≥10%). Conroy RM , Pyorala K, Fitzgerald AP et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur H J2003;24:987-1003.

  12 months

Secondary Outcomes (13)

• Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy

  12 months

• Adherence to CVD prevention recommendations

  12 months

• Systolic blood pressure

  12 months

• Diastolic blood pressure

  12 months

• Total cholesterol

  12 months

Study Arms (2)

Proactive CVD prevention

EXPERIMENTAL

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

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

Usual care

ACTIVE COMPARATOR

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

Other: Standard GP care

Interventions

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

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

Proactive CVD prevention

Standard GP care OTHER

Usual GP care (opportunistic CVD prevention)

Usual care

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alar Irs: lead
• North Estonia Regional Hospital: collaborator
• Tartu University Hospital: collaborator

Study Sites (2)

North Estonia Medical Centre

Tallinn, 13419, Estonia

Location

Tartu University Hospital

Tartu, 50406, Estonia

Location

Related Links

• Study general information and contacts

MeSH Terms

Conditions

Cardiovascular Diseases; Genetic Risk Score

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margus Viigimaa, MD, PhD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching physician in cardiology

Model Details: Large simple randomized trial

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 2, 2020
• Study Start: March 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)