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Cleerly Stage-Based Care for Prediabetes (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

TRANSFORM Trial 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.Check my eligibility
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.See study design
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.

TRANSFORM Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.
Secondary outcome measures
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 outcome measures
The safety objective is to assess harm with the 2 prevention strategies

TRANSFORM 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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Who is running the clinical trial?

CPC Clinical ResearchUNKNOWN
2 Previous Clinical Trials
540 Total Patients Enrolled
Cleerly, Inc.Lead Sponsor
2 Previous Clinical Trials
36,700 Total Patients Enrolled
Deepak Bhatt, MD, MPHStudy ChairMt. Sinai Heart
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being recruited for this study at the moment?

"As per the details on clinicaltrials.gov, this medical investigation is currently seeking eligible candidates. The trial was initially listed on March 6th, 2024 and underwent its latest update on March 8th of the same year."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
2024. "A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112418.
All > Metabolic Syndrome
~5000 spots leftby Mar 2029
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