There is uncertainty whether current strategies for providing CVD risk scores  affect CVD events .
Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm .
BACKGROUND The current paradigm for cardiovascular disease ( CVD ) emphasises absolute risk assessment to guide treatment decisions in primary prevention .
Although the derivation and validation of multivariable risk assessment tools , or CVD risk scores , have attracted considerable attention , their effect on clinical outcomes is uncertain .
OBJECTIVES To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes , risk factor levels , preventive medication prescribing , and health behaviours .
Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study
Background Whether disclosure of a genetic risk score ( GRS ) for a common disease influences relevant clinical outcomes is unknown . We describe design of the Myocardial Infa rct ion Genes ( MI-GENES ) Study , a r and omized clinical trial to assess whether disclosing a GRS for coronary heart disease ( CHD ) leads to lowering of low-density lipoprotein cholesterol ( LDL-C ) levels . Methods and design We performed an initial screening genotyping of 28 CHD susceptibility single-nucleotide polymorphisms ( SNPs ) that are not associated with blood pressure or lipid levels , in 1000 individuals from Olmsted County , Minnesota who were participants in the Mayo Clinic BioBank and met eligibility criteria . We calculated GRS based on 28 SNPs and will enroll 110 patients each in two CHD genomic risk categories : high ( GRS ≥1.1 ) , and average/low ( GRS < 1.1 ) . The study coordinator will obtain informed consent for the study that includes placing genetic testing results in the electronic health record . Participants will undergo a blood draw and return 6 - 10 weeks later ( Visit 2 ) once genotyping is completed and a GRS calculated . At this visit , patients will be r and omized ( 1:1 ) to receive CHD risk estimates from a genetic counselor based on a conventional risk score ( CRS ) vs. GRS , followed by shared decision making with a physician regarding statin use . Three and six months following the disclosure of CHD risk , participants will return for measurement of fasting lipid levels and assessment of changes in dietary fat intake and physical activity levels . Psychosocial measures will be assessed at baseline and after disclosure of CHD risk . Discussion The proposed trial will provide insights into the clinical utility of genetic testing for CHD risk assessment . Clinical trial registration Clinical Trials.gov registration number : NCT01936675
There is uncertainty whether current strategies for providing CVD risk scores  affect CVD events .
Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm .
BACKGROUND The current paradigm for cardiovascular disease ( CVD ) emphasises absolute risk assessment to guide treatment decisions in primary prevention .
Although the derivation and validation of multivariable risk assessment tools , or CVD risk scores , have attracted considerable attention , their effect on clinical outcomes is uncertain .
OBJECTIVES To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes , risk factor levels , preventive medication prescribing , and health behaviours .