A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events

Inclusion Criteria:

1. Provided electronic or written informed consent

2. Men > 55, women > 65 years of age

3. Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recentHbA1c 5.7 to 6.4% and/or fasting glucose 100-125 mg/dL [5.6-6.9 mmol/L]) and/ormetabolic syndrome. Metabolic syndrome is defined as > 3 of the following criteria (International Diabetes Federation 2006):

• Body mass index ≥ 27 kg/m2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asianmen (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)

• Fasting triglycerides ≥ 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia

• HDL-cholesterol (HDL-C) < 40 mg/dL (1.03 mmol/L) in men, <50 mg/dL (1.29mmol/L) in women or treatment for this lipid abnormality

• Systolic blood pressure (BP) ≥ 130 and/or diastolic BP≥ 85 mm Hg and/or treatedhypertension

• Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or HbA1c ≥ 5.7%

4. Have a device (e.g., smartphone, tablet, computer) for communication with thecentral cardiologist-led team managing drug treatment for the personalized caregroup

Exclusion Criteria:

1. History of symptomatic CVD defined as prior MI, exertional or unstable angina,ischemic stroke, claudication, arterial revascularization for atherosclerosis orother CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heartfailure

2. Planned arterial revascularization

3. Inability to complete screening CCTA or any condition that would increase the riskassociated with CCTA or increase likelihood of uninterpretable scan including:

4. eGFR < 60 mL/min/1.73 m2 by the Chronic Kidney Disease EpidemiologyCollaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD)equation (www.kidney.org/professionals/kdoqi/gfr_calculator)

5. Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screeninglaboratory values consistent with untreated hyperthyroidism. Participants withelevated thyroid-stimulating hormone (TSH) may be enrolled but should bereferred to their physician for evaluation for treatment.

6. Thyroid cancer in the previous five (5) years or planned radioactive iodinetreatment

7. Weight > 300 lbs. (136 kg) or above manufacturer-recommended limit for scannerand table at the site

8. Inability to hold breath for > 10 seconds

9. Active arrhythmia (atrial fibrillation, atrial flutter, frequent prematureatrial, or ventricular contractions) with poorly controlled rate (i.e., > 80beats per minute at screening or prior to CCTA)

10. Contraindication to dosing with beta blocker or nitroglycerin on day ofscreening CCTA

11. Any other factor that, in the opinion of the investigator, would increaseparticipant risk or increase the chance of an uninterpretable CCTA

12. Unsuitable as a trial participant in the opinion of the investigator for reasonsincluding significant left main stenosis (e.g. ≥ 70%; site will be notified byCleerly), other health condition with life expectancy < 3 years or being at risk ofpoor compliance with study procedures (e.g., active substance abuse or untreatedmental illness that, in the opinion of the investigator, is likely to adverselyaffect adherence or retention)