Cardiovascular DiseasesEstPerMedCVNCT04291157
Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk
A study testing CVD risk estimation incorporating the PRS and guideline based preventive interventions. and Standard GP care in people with Cardiovascular Diseases and Primary Prevention, run by Alar Irs at 2 sites in Estonia.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Primary Prevention
- What is being tested?
- CVD risk estimation incorporating the PRS and guideline based preventive interventions. and Standard GP care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesEstonia
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Estonia2 sites
North Estonia Medical Centre
Tallinn, 13419
Tartu University Hospital
Tartu, 50406
About this study
Official title: Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study
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).
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Primary Prevention
- Being tested
- CVD risk estimation incorporating the PRS and guideline based preventive interventions., Standard GP care
- Keywords
- Polygenic risk score
- Medical subject headings
- Cardiovascular Diseases, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard GP careOther
Usual GP care (opportunistic CVD prevention)
| Study group | Role | What they receive |
|---|---|---|
| Proactive CVD prevention | Experimental | Proactive invitation to total CVD risk estimation incorporating the PRS and provision of guideline based preventive interventions. Receives: 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). Receives: Other: Standard GP care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (13)
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.
Measured: 12 months
Adherence to CVD prevention recommendations
Adherence to CVD prevention recommendations - proportion of patients adhering to lifestyle advice as recorded by GP.
Measured: 12 months
Systolic blood pressure
Sitting systolic blood pressure measured by automated device at GP office, mmHg
Measured: 12 months
Diastolic blood pressure
Sitting diastolic blood pressure measured by automated device at GP office, mmHg
Measured: 12 months
Total cholesterol
mmol/L
Measured: 12 months
LDL cholesterol
mmol/L
Measured: 12 months
BMI
Body mass index, height (m) and weight (kg) combined (kg/m2)
Measured: 12 months
Waist circumference
cm, measured at GP office
Measured: 12 months
Smoking status
Self-reported smoking status as recorded at GP office
Measured: 12 months
Physical activity
Self-reported physical activity, min/week, as recorded at GP office
Measured: 12 months
Satisfaction of gene donors with intervention
Satisfaction of gene donors with intervention - descriptive questionnaire, analysed qualitatively
Measured: 12 months
Satisfaction of GPs with intervention
Satisfaction of GPs with intervention - descriptive questionnaire, analysed qualitatively
Measured: 12 months
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).
Measured: 12 months, modelled over lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Mar 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Large simple randomized trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alar Irs
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonia Regional Hospital, Tartu University Hospital
- Responsible party
- Sponsor-investigator, Alar Irs, University of Tartu
- Investigators
- Margus Viigimaa, MD, PhD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291157
- Sponsor's protocol ID
- EstPerMed CV
- Acronym
- EstPerMedCV
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04291157
- Acronym / sponsor ID
- EstPerMedCV / EstPerMed CV
- Conditions
- Cardiovascular Diseases, Primary Prevention
- Keywords
- Polygenic risk score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Alar IrsUniversity, hospital or other
- Collaborators
- North Estonia Regional Hospital, Tartu University Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Large simple randomized trial
| Arm | Type | Receives |
|---|---|---|
| Proactive CVD prevention | Experimental | Other: CVD risk estimation incorporating the PRS and guideline based preventive interventions.Proactive invitation to total CVD risk estimation incorporating the PRS and provision of guideline based preventive interventions. |
| Usual care | Active comparator | Other: Standard GP careUsual GP care (opportunistic CVD risk estimation and prevention upon usual GP contacts). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Proactive CVD prevention |
| Standard GP careUsual GP care (opportunistic CVD prevention) | Other | Usual care |
Primary outcome
Total 10 year cardiovascular disease (CVD) risk
Time frame: 12 months
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.
13 secondary outcomes
Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy
Time frame: 12 months
Adherence to CVD prevention recommendations
Time frame: 12 months
Systolic blood pressure
Time frame: 12 months
Diastolic blood pressure
Time frame: 12 months
Total cholesterol
Time frame: 12 months
LDL cholesterol
Time frame: 12 months
BMI
Time frame: 12 months
Waist circumference
Time frame: 12 months
Smoking status
Time frame: 12 months
Physical activity
Time frame: 12 months
Satisfaction of gene donors with intervention
Time frame: 12 months
Satisfaction of GPs with intervention
Time frame: 12 months
Cost-effectiveness of intervention
Time frame: 12 months, modelled over lifetime
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Study general information and contactsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margus Viigimaa, MD, PhD principal investigator
University of Tartu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVD risk estimation incorporating the PRS and guideline based preventive interventions. and Standard GP care in people with Cardiovascular Diseases and Primary Prevention, run by Alar Irs at 2 sites in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 10 year cardiovascular disease (CVD) risk (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.