1. Trial Details/Purpose

Cardiovascular disease (CVD) affects nearly 49% of U.S. adults, including conditions like heart disease, hypertension, and stroke. Heart disease remains the leading cause of death, with 697,000 deaths in 2020. Key risk factors include high blood pressure (47% of adults), high cholesterol (95 million adults), and smoking (14%). Stroke is the fifth leading cause of death.  It disproportionately impacts older adults, men, and racial/ethnic minorities, especially African Americans and Hispanics.  The TRANSFORM trial (202302CPC) is a clinical study designed to evaluate a new approach to preventing heart-related events, such as heart attacks and strokes, in individuals at increased risk but without known heart disease symptoms. The study compares two strategies: one based on personalized heart disease staging using advanced imaging technology (the Cleerly Coronary Artery Disease [CAD] Staging System) and the other based on traditional risk factor assessments. The goal is to determine if the imaging-based strategy can more effectively reduce cardiovascular events.​

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​2. Inclusion Criteria

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• Age and Health Status: Adults aged 18 years or older without known symptoms of heart disease.

• Increased Risk Factors: Individuals with conditions that elevate the risk of heart disease, such as:

  • Type 2 diabetes

  • Prediabetes

  • Metabolic syndrome

 

3. Exclusion Criteria

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• Existing Heart Conditions: Individuals with known symptomatic heart disease are excluded.

• Other Medical Conditions: Participants with health issues that could interfere with the study or pose additional risks may be excluded, though specific conditions are not detailed in the provided information.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location​

 

     Northridge​​​​​​