NCT06112418From ClinicalTrials.govRecruiting

A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events

A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events

Diabetes Mellitus, Type 2
PreDiabetes
Metabolic Syndrome

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: Cleerly, Inc.
Enrolment target: 7,500
Started: 6 March 2024
Main results due: 5 March 2029
Study sites: 125
Registry updated: 28 September 2026

Can you take part?

Aged 55 years and over.
Open to any sex.
Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Provided electronic or written informed consent
2. Men \> 55, women \> 65 years of age
3. Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and/or fasting glucose 100-125 mg/dL \[5.6-6.9 mmol/L\]) and/or metabolic syndrome. Metabolic syndrome is defined as \> 3 of the following criteria (International Diabetes Federation 2006):

   * Body mass index ≥ 27 kg/m2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)
   * Fasting triglycerides ≥ 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia
   * HDL-cholesterol (HDL-C) \< 40 mg/dL (1.03 mmol/L) in men, \<50 mg/dL (1.29 mmol/L) in women or treatment for this lipid abnormality
   * Systolic blood pressure (BP) ≥ 130 and/or diastolic BP≥ 85 mm Hg and/or treated hypertension
   * Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or HbA1c ≥ 5.7%
4. Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group

Exclusion Criteria:

1. History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure
2. Planned arterial revascularization
3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:

   1. eGFR \< 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org/professionals/kdoqi/gfr\_calculator)
   2. Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.
   3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
   4. Weight \> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site
   5. Inability to hold breath for \> 10 seconds
   6. Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \> 80 beats per minute at screening or prior to CCTA)
   7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA
   8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
4. Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \< 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(125)

Chandler Clinical Trials
Chandler, Arizona, United States
Recruiting
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Recruiting
Sun City Research
Sun City, Arizona, United States
Recruiting
Noble Clinical Research
Tucson, Arizona, United States
Recruiting
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
Recruiting
Amicis Research: Beverly Hills
Beverly Hills, California, United States
Recruiting
Valiance Clinical Research - Canoga Park
Canoga Park, California, United States
Recruiting
Cardiovascular Institute of San Diego
Chula Vista, California, United States
Recruiting
Amicis Research: Granada Hills
Granada Hills, California, United States
Recruiting
Valiance Clinical Research: Huntington Park
Huntington Park, California, United States
Recruiting
HALO Diagnostics
Indian Wells, California, United States
Recruiting
Scripps Health
La Jolla, California, United States
Recruiting
Chemidox Clinical Trials
Lancaster, California, United States
Recruiting
Loma Linda University Health
Loma Linda, California, United States
Recruiting
Long Beach Research Institute
Long Beach, California, United States
Recruiting
Ace Research Institute - Monterey Park
Monterey Park, California, United States
Recruiting
Amicis Research: Newhall
Newhall, California, United States
Recruiting
Ace Research Institute: Northridge
Northridge, California, United States
Recruiting
Amicis Research: Northridge
Northridge, California, United States
Recruiting
Ace Research Institute: Northridge #2
Northridge, California, United States
Recruiting
Northridge Clinical Trials
Northridge, California, United States
Active, not recruiting
University of California- Irvine
Orange, California, United States
Recruiting
Stanford Health Care
Palo Alto, California, United States
Recruiting
VA Palo Alto
Palo Alto, California, United States
Recruiting
Amicis Research: San Fernando
San Fernando, California, United States
Recruiting
Valiance Clinical Research - Tarzana
Tarzana, California, United States
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
Recruiting
Amicis Research: Valencia
Valencia, California, United States
Recruiting
Concierge Clinical Trials
Valley Village, California, United States
Recruiting
University of Colorado
Aurora, Colorado, United States
Recruiting
St. Josephs (Intermountain Healthcare)
Denver, Colorado, United States
Recruiting
Flourish Medical Research
Boca Raton, Florida, United States
Recruiting
Apex Research
Cross City, Florida, United States
Recruiting
Evolution Research Center
Hialeah, Florida, United States
Recruiting
UF Health Jacksonville
Jacksonville, Florida, United States
Recruiting
Fiel Wellness Clinical Research LLC
Miami, Florida, United States
Recruiting
BioPhase Research
Miami, Florida, United States
Recruiting
United Clinical Research
Miami, Florida, United States
Recruiting
Atlantis Clinical Research, LLC
Miami, Florida, United States
Recruiting
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, United States
Recruiting
Farma Medical Inc.
Miami, Florida, United States
Recruiting
New Access Research and Medical Center
Miami, Florida, United States
Recruiting
Quantum Clinical Trials
Miami Beach, Florida, United States
Recruiting
Ascension Sacred Heart
Pensacola, Florida, United States
Recruiting
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
Aiyan Diabetes Center
Augusta, Georgia, United States
Recruiting
Emory University
Dunwoody, Georgia, United States
Recruiting
Privia Medical Group Georgia LLC -Fayetteville (Javara)
Fayetteville, Georgia, United States
Recruiting
Randomize Now- Atlanta West
Lithia Springs, Georgia, United States
Recruiting
Randomize Now-Burton Medical
Macon, Georgia, United States
Recruiting
Evergreen Clinical Trials
Norcross, Georgia, United States
Recruiting
Peachtree Clinical Solutions - Noir Research Collective
Powder Springs, Georgia, United States
Recruiting
Randomize Now, LLC - Noir Research Collective
Riverdale, Georgia, United States
Recruiting
Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah, Georgia, United States
Recruiting
Privia Medical Group Georgia - Thomasville (Javara)
Thomasville, Georgia, United States
Recruiting
Care Institute- High Desert
Meridian, Idaho, United States
Recruiting
Northwestern University
Chicago, Illinois, United States
Recruiting
Northshore University Health System
Glenview, Illinois, United States
Recruiting
Indiana Medical Research Institute
Indianapolis, Indiana, United States
Recruiting

Showing 60 of 125 sites — filter to narrow it down. 122 of the 125 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06112418. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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