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

Plain English Summary

A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events is a Not Applicable clinical trial sponsored by Cleerly, Inc. studying Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome. This trial tests if a new system that stages coronary artery disease (CAD) is better at preventing heart attacks and strokes than the current method of managing risk factors like high blood pressure and cholesterol. It is for individuals who are at higher risk for heart disease but do not currently have symptoms of it, specifically those with type 2 diabetes, prediabetes, or metabolic syndrome. Participation involves being randomly assigned to one of two groups: one receiving care guided by the Cleerly CAD Staging System, and the other receiving standard risk factor management. The alternative to participating is continuing with the current standard of care for managing cardiovascular risk factors. The trial aims to enroll 7500 participants.

Official Summary

TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.

Who Can Participate

Here is what you need to know about eligibility for this trial. You may be able to join if you are a man over 55 or a woman over 65, have type 2 diabetes, prediabetes, or metabolic syndrome, and have a device for communication. You cannot join if you have a history of symptomatic heart disease (like a heart attack or stroke), are planning heart procedures, or have certain kidney or thyroid conditions. Specific health requirements include not having kidney disease (eGFR < 60), no iodine contrast allergy, and being able to hold your breath for at least 10 seconds. Individuals with uncontrolled arrhythmias, certain thyroid issues, or those weighing over 300 lbs may also be excluded. This trial is studying Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures whether the new stage-based care strategy is more effective than standard risk factor management in reducing the occurrence of major cardiovascular events like heart attac The specific primary outcome measures are: The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events. (Through study completion- an average of 3.5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it explores a novel approach to identify and manage coronary artery disease earlier, potentially filling a gap in preventing cardiovascular events in individuals at high ris This research targets Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome, where improved treatment options are needed.

Investor Insight

This trial signals a significant investment in AI-driven diagnostic tools for cardiovascular disease, targeting a large market of at-risk individuals and aiming to improve preventative care, with a mo The large enrollment target of 7500 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your current risk factors are being managed optimally and if you might be a candidate for this trial. Participation will involve regular check-ups and potentially different medication management strategies depending on which group you are assigned to. You will need to have a special scan (CCTA) to assess your coronary arteries, and you'll need to be able to communicate with the care team via a digital device. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 7,500 participants

Interventions

• DEVICE: The Cleerly CAD Staging System — The Cleerly CAD Staging System is software that utilizes a proprietary algorithm to identify CAD, stage the severity of CAD when present, and generate a prognostic risk score to inform treatment decisions that support CV disease prevention.

Primary Outcomes

• The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events. (Through study completion- an average of 3.5 years)

Secondary Outcomes

• The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality. (Through study completion- an average of 3.5 years)
• The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality. (Through study completion- an average of 3.5 years)
• The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality. (Through study completion- an average of 3.5 years)
• The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality. (Through study completion- an average of 3.5 years)
• The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality. (Through study completion- an average of 3.5 years)

Full Eligibility 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)

Trial Locations

• Chandler Clinical Trials, Chandler, Arizona, United States
• Scottsdale Clinical Trials, Scottsdale, Arizona, United States
• Sun City Research, Sun City, Arizona, United States
• Noble Clinical Research, Tucson, Arizona, United States
• Cardiovascular Research Foundation of Southern California, Beverly Hills, California, United States
• Amicis Research: Beverly Hills, Beverly Hills, California, United States
• Valiance Clinical Research - Canoga Park, Canoga Park, California, United States
• Cardiovascular Institute of San Diego, Chula Vista, California, United States
• Amicis Research: Granada Hills, Granada Hills, California, United States
• Valiance Clinical Research: Huntington Park, Huntington Park, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Coronary Artery Disease
• Cardiovascular Disease
• Diabetes Mellitus, Type 2
• Prediabetes
• Metabolic Syndrome
• Hypertension
• Hyperlipidemia
• Atherosclerosis
• Heart Attack Prevention
• Stroke Prevention

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