Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based
Study Description
Cardiovascular disease (CVD) persists as the leading cause of morbidity and mortality worldwide at high societal cost. The current primary CVD prevention strategy relies upon risk stratification using population health markers such as age, sex, diabetes, hypertension, dyslipidemia and tobacco use, with preventive therapy intensified in higher risk strata. Since these risk factors are indirect surrogate markers of the underlying disease, atherosclerosis, this strategy leads to treatment of individuals with risk factors who do not have atherosclerosis and failure to treat those with significant atherosclerosis who lack risk factors. The current strategy also cannot determine which individuals are inadequately treated despite effective risk factor management (residual risk). With the current approach, the CV death rate is trending upward in the US despite evidence that screening asymptomatic patients reduces CV events and the widespread availability of effective preventive therapies.
This randomized, controlled, pragmatic trial is designed to address the unmet need for better strategies to identify asymptomatic individuals at increased risk for CV events due to atherosclerosis and to personalize their treatment based on CV risk estimates using coronary artery disease (CAD) visualization and quantification.
This study enrolls patients without known symptoms of ASCVD but who are at increased risk for ASCVD due to their age and having diabetes, prediabetes or metabolic syndrome and tests the hypothesis that a CAD Staging System-based care strategy reduces CV events compared with risk factor-based care. The Cleerly CAD Staging System incorporates imaging-based evaluation for coronary atherosclerosis, algorithm-supported pharmacotherapy and personalized education about their CAD.
Eligibility
- Provided electronic or written informed consent
- Men greater than 55, women greater than 65 years of age
- Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and/or fasting glucose 100-125 mg/dL [5.6-6.9 mmol/L]) and/or metabolic syndrome. Metabolic syndrome is defined as greater than 3 of the following criteria (International Diabetes Federation 2006):
- Body mass index greater than or equal to 27 kg/m2 or abnormal waist circumference defined as greater than or equal to 80 cm (31.5 inches) for women, greater than or equal to 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) greater than or equal to 90 cm (35.4 inches)
- Fasting triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia
- HDL-cholesterol (HDL-C) less than 40 mg/dL (1.03 mmol/L) in men, less than 50 mg/dL (1.29 mmol/L) in women or treatment for this lipid abnormality
- Systolic blood pressure (BP) greater than or equal to 130 and/or diastolic BP greater than or equal to 85 mm Hg and/or treated hypertension
- Fasting blood glucose greater than or equal to 100 mg/dL (5.6 mmol/L) or HbA1c greater than or equal to; 5.7%
- Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group
- History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure
- Planned arterial revascularization
- Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:
- eGFR less than 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org/professionals/kdoqi/gfr_calculator)
- Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.
- Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
- Weight greater than 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site
- Inability to hold breath for greater than 10 seconds
- Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., greater than 80 beats per minute at screening or prior to CCTA)
- Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA
- Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
- Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. greater than or equal to 70%; site will be notified by Cleerly), other health condition with life expectancy less than 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)
