7500 Participants Needed

Cleerly CAD Staging System for Preventing Heart Disease

(TRANSFORM Trial)

Recruiting at 95 trial locations
MM
AM
NK
AE
SS
JR
MD
RP
Overseen ByRonald P. Karlsberg, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cleerly, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

How is the Cleerly CAD Staging System treatment different from other treatments for coronary artery disease?

The Cleerly CAD Staging System is unique because it focuses on personalized risk assessment using coronary artery calcium scoring, which provides additional prognostic information beyond traditional clinical assessments. This approach is relatively inexpensive and involves a small radiation dose, offering a novel way to guide prevention strategies for coronary artery disease.12345

What data supports the effectiveness of the Cleerly CAD Staging System treatment for preventing heart disease?

The research highlights the importance of standardized outcome measurement for coronary artery disease (CAD), suggesting that when outcomes are routinely measured and shared with healthcare providers, patient results improve. This implies that the Cleerly CAD Staging System, which likely involves systematic tracking and assessment, could be effective in improving CAD outcomes.26789

Who Is on the Research Team?

DB

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).
See 5 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cleerly Stage-Based CareExperimental Treatment1 Intervention
Group II: Risk Factor-Based CareActive Control1 Intervention

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:

Find a Clinic Near You

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

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

Citations

End points for comparative effectiveness research in heart failure. [2021]
Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). [2022]
Prediction of presence and severity of coronary artery disease using prediction for atherosclerotic cardiovascular disease risk in China scoring system. [2021]
FRISC score for selection of patients for an early invasive treatment strategy in unstable coronary artery disease. [2018]
Clinical prediction model for death prior to appropriate therapy in primary prevention implantable cardioverter defibrillator patients with ischaemic heart disease: the FADES risk score. [2022]
Rationale and design of a trial to personalize risk assessment in familial coronary artery disease. [2019]
[Digital risk analysis of cardiovascular diseases: new opportunities for the patients. Cardiovascular prevention program in the praxis]. [2009]
Screening for cardiovascular disease risk using traditional risk factor assessment or coronary artery calcium scoring: the ROBINSCA trial. [2021]
Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a community guide systematic review. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security