Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Total 10 year cardiovascular disease (CVD) risk
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Total 10 year cardiovascular disease (CVD) risk
时间窗: 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.
次要结局
- Satisfaction of GPs with intervention(12 months)
- Cost-effectiveness of intervention(12 months, modelled over lifetime)
- Diastolic blood pressure(12 months)
- Total cholesterol(12 months)
- Adherence to CVD prevention recommendations(12 months)
- Systolic blood pressure(12 months)
- Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy(12 months)
- LDL cholesterol(12 months)
- BMI(12 months)
- Waist circumference(12 months)
- Smoking status(12 months)
- Physical activity(12 months)
- Satisfaction of gene donors with intervention(12 months)
研究者
Alar Irs
Teaching physician in cardiology
University of Tartu