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TRANSFORM Study: Comparing Heart Disease Prevention Strategies

The TRANSFORM study is comparing two ways to prevent heart disease in people at higher risk. It's testing if using the Cleerly CAD Staging System, a software that identifies and stages coronary artery disease (CAD) to guide treatment, is better than the usual care based on risk factors like age and diabetes. This study is for men over 55 and women over 65 who have type 2 diabetes, prediabetes, or metabolic syndrome. The main goal is to see if the Cleerly system can reduce heart-related problems over an average of 3.5 years. The study aims to enroll 7500 participants.

Study design
This is a randomized, controlled study, meaning participants are assigned by chance to one of two care strategies. It is an open blinded endpoint (PROBE) trial, and plans to enroll 7500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 3.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06112418

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

Recruiting
NAAges 55+InterventionalPrevention
Cleerly, Inc.
~7,500 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:The Cleerly CAD Staging System

At a glance

Recruiting sites
122 of 125 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.
Measured over Through study completion- an average of 3.5 years

Conditions

Diabetes Mellitus, Type 2
PreDiabetes
Metabolic Syndrome

Explore related trials

Metabolic SyndromePrediabetesType 2 Diabetes Mellitus

Where it's being run

125 sites across 33 states
California25
Florida15
Texas13
Georgia10
New York7
North Carolina6
New Jersey5
Arizona4

Study leadership

  • Deepak Bhatt, MD, MPH · STUDY_CHAIR · Mt. Sinai Heart
  • David J. Maron, MD, FASPC · STUDY_CHAIR · Stanford University

Who to contact

Ryann Sardinia
[email protected]
7207398191
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • 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

    The primary endpoint is total (first and subsequent) events for the composite endpoint of CV death, myocardial infarction (MI), ischemic stroke, acute limb ischemia, clinically driven arterial revascularization, and hospitalization or urgent visit for heart failure.