Cleerly CAD Staging System for Preventing Heart Disease

(TRANSFORM Trial)

Recruiting at 112 trial locations

Overseen By Ronald P. Karlsberg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cleerly, Inc.

Disqualifiers: Symptomatic CVD, Kidney disease, Thyroid cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3.5 years

7500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new care strategy using the Cleerly CAD Staging System, a diagnostic tool for assessing coronary artery disease, can better prevent heart problems compared to standard care based on risk factors. It targets individuals with conditions like type 2 diabetes or metabolic syndrome, which increase the risk of heart disease, but who do not yet show symptoms. Participants will either receive personalized care based on their Cleerly CAD results or continue with their usual care. This trial suits those managing conditions like diabetes or high blood pressure and who have access to a smartphone or computer for communication with the care team. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could enhance heart health management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Cleerly CAD Staging System is safe for preventing heart disease?

Research has shown that the Cleerly CAD Staging System is designed to manage heart disease by using advanced technology to analyze the arteries. Although specific safety data is not yet available, the system has received FDA Breakthrough Device Designation. This designation indicates promise in safety and effectiveness, as it is awarded to devices that might offer improved treatment or diagnosis for serious diseases.

The trial's phase is labeled as "Not Applicable," indicating that safety is still under careful study. However, the system's acceptance into the FDA's TAP pilot program demonstrates that it is undergoing a thorough safety review for use in medical settings.

In summary, while specific safety data is not yet available, experts regard the Cleerly CAD Staging System highly, and it has gained significant attention from the FDA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cleerly CAD Staging System because it offers a personalized approach to preventing heart disease by using advanced imaging to guide treatment. Unlike the standard risk factor-based care, which relies on general guidelines and patient history, the Cleerly system uses detailed imaging results to tailor treatment plans specifically for each patient. This method allows for more precise adjustments in medication and lifestyle interventions based on actual plaque progression, potentially improving outcomes and preventing heart disease more effectively.

What evidence suggests that the Cleerly CAD Staging System is effective for preventing heart disease?

Research has shown that the Cleerly Coronary Artery Disease (CAD) Staging System aids in understanding heart disease by measuring plaque buildup in the arteries. This system employs non-invasive imaging to examine the heart and assess heart attack risk. In this trial, participants in the Cleerly Stage-Based Care arm will receive personalized care using this system. Studies suggest it can enhance heart disease management by tailoring treatments based on staging results. Early findings indicate that this personalized care might reduce heart problems compared to the Risk Factor-Based Care arm, which follows standard care based on general risk factors. This approach enables doctors to adjust treatments if a patient's plaque buildup increases over time. ^{1 2 3 4 5}

Who Is on the Research Team?

Deepak Bhatt, MD, MPH

Principal Investigator

Mt. Sinai Heart

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have offered your consent via an electronic or written agreement.

I am a man over 55 or a woman over 65.

You have a body mass index of at least 27 kg/m2 or an abnormal waist circumference greater than 80 cm (31.5 inches) for women, 94 cm (37 inches) for men, and 90 cm (35.4 inches) for South and East Asian men (e.g., Asian Indian, Chinese, Japanese).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-randomization Assessment

Initial assessment of current treatment by a centralized cardiology team to optimize care relative to primary prevention guidelines

4 weeks

1 visit (in-person)

Treatment

Participants receive either Cleerly Stage-Based Care or Risk Factor-Based Care, with ongoing monitoring and feedback

3.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• The Cleerly CAD Staging System

Trial Overview 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.

How Is the Trial Designed?

Group I: Cleerly Stage-Based Care Experimental Treatment 1 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 Care Active Control 1 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.

The Cleerly CAD Staging System is already approved in United States for the following indications:

Approved in United States as Cleerly CAD Staging System for:

• Prevention of cardiovascular events in patients at increased risk for atherosclerotic cardiovascular disease

Who Is Running the Clinical Trial?

Cleerly, Inc.

Lead Sponsor

Trials

4

Recruited

45,200+

CPC Clinical Research

Collaborator

Trials

3

Recruited

8,000+

Published Research Related to This Trial

A study of 900 patients with ischaemic heart disease who received an implantable cardioverter defibrillator (ICD) showed that certain factors like advanced age, diabetes, and low heart function can help predict the risk of death without prior ICD therapy.

The 5-year risk of death without appropriate ICD therapy varied significantly, from 10% in low-risk patients to 41% in high-risk patients, allowing for tailored risk assessments in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical prediction model for death prior to appropriate therapy in primary prevention implantable cardioverter defibrillator patients with ischaemic heart disease: the FADES risk score. van Rees, JB., Borleffs, CJ., van Welsenes, GH., et al.[2022]

The CAUGHT-CAD trial aims to evaluate the effectiveness of coronary artery calcium scoring (CCS) in guiding primary prevention strategies for individuals aged 40 to 70 with a family history of premature coronary artery disease (CAD), focusing on changes in plaque volume over 3 years.

This study will compare CCS-informed prevention strategies against standard risk assessments, potentially providing crucial evidence to support the inclusion of CCS in clinical guidelines for patients at higher risk due to family history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a trial to personalize risk assessment in familial coronary artery disease. Marwick, TH., Whitmore, K., Nicholls, SJ., et al.[2019]

The International Consortium for Health Outcomes Measurement (ICHOM) has established a consensus standard set of 13 outcome measures for tracking and improving care in patients with coronary artery disease (CAD), which includes both immediate and long-term health outcomes.

These measures are designed to be applicable to all CAD patients, including those with acute myocardial infarction and asymptomatic CAD, and aim to enhance the quality of care by providing relevant data for physicians and hospitals to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). McNamara, RL., Spatz, ES., Kelley, TA., et al.[2022]

The China-PAR scoring system was evaluated in a study of 6813 patients undergoing coronary angiography and showed a significant correlation with the severity of coronary artery disease (CAD) as measured by the Gensini score.

The scoring system demonstrated moderate predictive ability for both the presence and severity of CAD, with cut-off values around 7.55% and 7.45%, respectively, indicating it could be a practical tool for primary prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of presence and severity of coronary artery disease using prediction for atherosclerotic cardiovascular disease risk in China scoring system. Hong, XL., Chen, H., Li, Y., et al.[2021]

A scoring system developed from a study of 2457 patients with unstable coronary artery disease identified seven key risk factors that can predict mortality and myocardial infarction, including age, sex, diabetes, and specific heart-related markers.

In patients with five or more risk factors, an early invasive treatment strategy significantly reduced mortality from 15.4% to 5.2%, demonstrating that this approach can be particularly effective for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FRISC score for selection of patients for an early invasive treatment strategy in unstable coronary artery disease. Lagerqvist, B., Diderholm, E., Lindahl, B., et al.[2018]

A new software tool was developed to help prevent coronary and vascular diseases by visually comparing a patient's coronary risk against normal risk factors over time.

The program allows for tracking changes in coronary risk status over a 4-year period, which can enhance treatment effectiveness and improve patient care through better understanding of risk alterations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Digital risk analysis of cardiovascular diseases: new opportunities for the patients. Cardiovascular prevention program in the praxis]. Arnold, C., Englert, Z., Szabadhegyi, C., et al.[2009]

In the ROBINSCA trial, which included over 28,000 participants, coronary artery calcium (CAC) scoring identified significantly fewer individuals at high risk for cardiovascular disease compared to the SCORE model, suggesting it may be a more conservative approach to risk assessment.

CAC scoring led to a notable reduction in the number of individuals recommended for preventive treatment, with a 37.2% reduction in women and 28.8% in men, indicating that it may help avoid unnecessary treatments for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for cardiovascular disease risk using traditional risk factor assessment or coronary artery calcium scoring: the ROBINSCA trial. van der Aalst, CM., Denissen, SJAM., Vonder, M., et al.[2021]

Current Comparative Effectiveness Research (CER) for heart failure must move away from using surrogate endpoints and instead focus on direct measures of clinical effectiveness and safety, including health status and resource utilization.

To achieve this, there is a need for more prospective studies with proactive endpoint capture, ideally through randomized trials, to ensure reliable comparisons of different heart failure interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End points for comparative effectiveness research in heart failure. Allen, LA., Spertus, JA.[2021]

The review of 21 studies on clinical decision support systems (CDSSs) for preventing cardiovascular disease (CVD) found significant variability in costs and benefits, making it hard to estimate their overall economic impact.

While some studies suggested that CDSSs could reduce healthcare costs, many did not comprehensively assess all relevant factors, leading to inconclusive results about their cost-effectiveness and net benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a community guide systematic review. Jacob, V., Thota, AB., Chattopadhyay, SK., et al.[2022]

Citations

1. cleerlyhealth.com cleerlyhealth.com/blog/new-staging-system-for-coronary-artery-disease

New Staging System for Coronary Artery Disease New research proposes a four-stage system for measuring the progression of cardiovascular disease (CAD) based on atherosclerotic plaque ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06112418

NCT06112418 | A Randomized Comparison of Stage- ... 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 ...

3. cleerlyhealth.com cleerlyhealth.com/

Cleerly: Personalized Analysis and Treatment of Heart Disease Cleerly determines your risk of heart attack by performing a non-invasive whole heart assessment to identify, characterize, and quantify plaque buildup.

4. cleerlyhealth.com cleerlyhealth.com/press/breakthrough-device-designation-heart-disease-risk-staging-system

Cleerly Receives FDA BDD for Heart Disease Staging ... The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary ...

5. withpower.com withpower.com/trial/phase-metabolic-syndrome-10-2023-f12d5

Cleerly CAD Staging System for Preventing Heart 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 ...