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Comparing two care strategies for preventing cardiovascular events in at-risk patients

A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events

Not applicable Interventional Cleerly, Inc. · NCT06112418

This study tests if a new care strategy based on a detailed look at coronary artery disease can better prevent heart problems in people at risk but without symptoms, compared to the usual approach.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment7500 (estimated)
Ages55 Years and up
SexAll
SponsorCleerly, Inc. Industry-sponsored
Locations123 sites (Chandler, Arizona and 122 other locations)
Trial IDNCT06112418 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy compared to traditional risk factor-based care in preventing cardiovascular events. It targets patients who are at increased risk for atherosclerotic cardiovascular disease (ASCVD) but do not have known symptoms. The study employs a randomized, controlled, pragmatic design to personalize treatment based on coronary artery disease visualization and quantification. By focusing on asymptomatic individuals with diabetes, prediabetes, or metabolic syndrome, the trial aims to improve identification and management of those at risk for cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates include men over 55 and women over 65 with type 2 diabetes, prediabetes, or metabolic syndrome.

Not a fit: Patients with known symptomatic cardiovascular disease or those without the specified risk factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective prevention of cardiovascular events in high-risk patients.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cardiovascular risk assessment, suggesting potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 \> 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 Asian men (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 (1.29 mmol/L) in women or treatment for this lipid abnormality
   * Systolic blood pressure (BP) ≥ 130 and/or diastolic BP≥ 85 mm Hg and/or treated hypertension
   * 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 the central cardiologist-led team managing drug treatment for the personalized care group

Exclusion Criteria:

1. 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
2. Planned arterial revascularization
3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:

   1. eGFR \< 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)
   2. 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.
   3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
   4. Weight \> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site
   5. Inability to hold breath for \> 10 seconds
   6. Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \> 80 beats per minute at screening or prior to CCTA)
   7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA
   8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
4. Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \< 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)

Where this trial is running

Chandler, Arizona and 122 other locations

+73 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 2PreDiabetesMetabolic Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.