Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk

Cardiovascular Diseases Clinical Trial

— EstPerMedCV  

Official title:

Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04291157
• Other study ID #: EstPerMed CV
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Primary Prevention

Intervention

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.
• Standard GP care
Usual GP care (opportunistic CVD prevention)

Locations

Country	Name	City	State
Estonia	North Estonia Medical Centre	Tallinn
Estonia	Tartu University Hospital	Tartu

Sponsors (3)

Lead Sponsor	Collaborator
Alar Irs	North Estonia Regional Hospital, Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy	New prescription or a dose escalation of any anti-hypertensive, lipid lowering, anti-platelet or anti-smoking medicinal product.	12 months
Secondary	Adherence to CVD prevention recommendations	Adherence to CVD prevention recommendations - proportion of patients adhering to lifestyle advice as recorded by GP.	12 months
Secondary	Systolic blood pressure	Sitting systolic blood pressure measured by automated device at GP office, mmHg	12 months
Secondary	Diastolic blood pressure	Sitting diastolic blood pressure measured by automated device at GP office, mmHg	12 months
Secondary	Total cholesterol	mmol/L	12 months
Secondary	LDL cholesterol	mmol/L	12 months
Secondary	BMI	Body mass index, height (m) and weight (kg) combined (kg/m2)	12 months
Secondary	Waist circumference	cm, measured at GP office	12 months
Secondary	Smoking status	Self-reported smoking status as recorded at GP office	12 months
Secondary	Physical activity	Self-reported physical activity, min/week, as recorded at GP office	12 months
Secondary	Satisfaction of gene donors with intervention	Satisfaction of gene donors with intervention - descriptive questionnaire, analysed qualitatively	12 months
Secondary	Satisfaction of GPs with intervention	Satisfaction of GPs with intervention - descriptive questionnaire, analysed qualitatively	12 months
Secondary	Cost-effectiveness of intervention	Incremental cost-effectiveness ratio (EUR/QALY): cost of intervention combined in an economic model with lifetime benefit (number of quality adjusted life years modelled based on change in total CVD risk, measured as primary endpoint).	12 months, modelled over lifetime

External Links

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