Effectiveness of a Proactive Cardiovascular Primary Prevention Strategy, With or Without the Use of Coronary Calcium Screening, in Preventing Future Major Adverse Cardiac Events

This is a randomized, open-label study designed to assess the effectiveness of coronary
calcium screening. Patients who provide consent, and are eligible, will be randomized 1:1 to
receive statin treatment based on coronary calcium screening results or standard risk
assessment results using the American Heart Association/American College of Cardiology
(AHA/ACC)-recommended pooled cohort equation.

Management of all participants will be done through their primary care physicians/clinicians
who will receive education and training from the Principal Investigator and/or his delegate
about the two treatment strategies. The pooled cohort group will be managed following the
AHA/ACC guidelines for statin initiation and follow-up. The coronary artery calcium (CAC)
group will undergo coronary artery calcium screening and will receive statin treatment based
on the proposed CAC cardiovascular (CV) risk algorithm. All subjects will be asked to
complete the Intermountain Statin Adherence Questionnaire (ISAQ) at 3 months after study
enrollment (+ 30 days) and then annually thereafter (within + 30 days of the anniversary date
of enrollment) for five years. All subjects will remain under the usual care of their primary
care physicians and will be followed by the study team via their electronic health records
(EHR) for approximately an average of 4 years following enrollment, but until the target
primary endpoint event rate is met. All subjects will be followed for outcomes and this will
be completely done by electronic medical records query. Other than the visit to obtain
agreement for study participation and to perform the CAC screening, there will be no other
study-specific clinic visits required. Further, there will be no other treatments or
procedures required for this study.

Inclusion Criteria:

1. Male or female subjects 50 to 85 years of age, of any ethnic origin

2. Ability to understand and provide agreement to study participation, which must be
obtained prior to initiation of any study procedures

3. No known history, as documented in the EHR, of coronary artery disease,
cerebrovascular disease, peripheral vascular disease, or diabetes mellitus at
enrollment

4. Not on treatment with statins at the time of consent

5. Willing and able to provide access to their EHR until study end

6. Willing and able to undergo a computed tomography (CT) coronary artery calcium
screening test

7. Current and/or past patients seen at Intermountain facilities and who have accessible
EHR at the facility(ties) where they are seen.

Exclusion Criteria:

1. Have a major co-morbidity that may make it difficult for the subject to complete the
study (e.g. active on-going cancer; end-stage kidney disease, glomerular filtration
rate (GFR) < 30, or patients on dialysis; respiratory insufficiency such that the
patient requires continuous oxygen; systolic heart failure with left ventricular
ejection fraction (LVEF) < 40%; severe dementia or other psychiatric illness such that
the patient cannot provide informed consent; any other comorbidity as assessed by the
Principal Investigator)

2. Have a life expectancy of less than 24 months

3. Any evidence of statin use prior to study participation

4. Participation in any other clinical trials involving investigational or marketed
products within 30 days prior to entry in the study

5. Other conditions that in the opinion of the Principal Investigator and/or Co-Principal
Investigator may increase risk to the subject and/or compromise the quality of the
clinical trial

6. The Study Doctor(s) determine(s) that the subject is not eligible for participation in
this research study

7. The subject is non-English speaking, and therefore may be unable to fully understand
the written and spoken instructions that may relate to the proper conduct of the trial