Cleerly CAD Staging System for Preventing Heart Disease (TRANSFORM Trial)

N/A

Recruiting

Research Sponsored by Cleerly, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion- an average of 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial, called TRANSFORM, is testing a new way to care for patients at risk for heart disease but who do not have any symptoms of heart disease. The trial will compare a new care strategy

Who is the study for?

This trial is for men over 55 and women over 65 with a higher body mass index or large waist circumference, high blood pressure, elevated fasting blood glucose or HbA1c levels, access to a smart device for communication, and certain lipid abnormalities. It's not suitable for those with symptomatic cardiovascular disease.

What is being tested?

The TRANSFORM trial is testing if the Cleerly Coronary Artery Disease Staging System can better prevent cardiovascular events in at-risk patients compared to traditional risk factor-based care. This study randomly assigns participants to one of these two strategies.

What are the potential side effects?

Since this trial involves diagnostic staging systems rather than medications, direct side effects are minimal. However, any subsequent treatments based on the staging results may carry their own risks and side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion- an average of 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion- an average of 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion- an average of 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.

Secondary study objectives

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.

Other study objectives

The safety objective is to assess harm with the 2 prevention strategies

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cleerly Stage-Based CareExperimental Treatment1 Intervention

The Cleerly Stage-Based Care group will receive personalized care centrally managed by a remote cardiologist-led team. They will also receive an initial pre-randomization assessment of current treatment by a centralized cardiology team to optimize care relative to primary prevention guidelines. Cleerly CAD Staging System results will be discussed with participants and serve as the basis for standardized algorithm-supported pharmacotherapy \& education, which will be intensified if plaque burden has progressed at 24 months.

Group II: Risk Factor-Based CareActive Control1 Intervention

The risk factor-based care group will be managed by their usual care providers, with an initial pre-randomization assessment of current treatment by a centralized cardiology team to optimize care relative to primary prevention guidelines. During the trial, the centralized cardiology team will monitor the provision of medications prescribed and lab values relative to guidelines, and provide feedback and education to site investigators to support optimization. CCTA results will be centrally archived and will remain blinded to the usual care provider until the end of the study.

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