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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Cleerly, Inc. • ClinicalTrials.gov ID: NCT06112418

Registry updated: 2026-09-28
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Description

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.

Interventions

  • The Cleerly CAD Staging System (Device)
    The Cleerly CAD Staging System is software that utilizes a proprietary algorithm to identify CAD, stage the severity of CAD when present, and generate a prognostic risk score to inform treatment decisions that support CV disease prevention.

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)

Conditions

Diabetes Mellitus, Type 2 PreDiabetes Metabolic Syndrome

Locations

  • Chandler Clinical Trials — Chandler, Arizona, United States
  • Scottsdale Clinical Trials — Scottsdale, Arizona, United States
  • Sun City Research — Sun City, Arizona, United States
  • Noble Clinical Research — Tucson, Arizona, United States
  • Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States
  • Amicis Research: Beverly Hills — Beverly Hills, California, United States
  • Valiance Clinical Research - Canoga Park — Canoga Park, California, United States
  • Cardiovascular Institute of San Diego — Chula Vista, California, United States
  • Amicis Research: Granada Hills — Granada Hills, California, United States
  • Valiance Clinical Research: Huntington Park — Huntington Park, California, United States
  • HALO Diagnostics — Indian Wells, California, United States
  • Scripps Health — La Jolla, California, United States
  • Chemidox Clinical Trials — Lancaster, California, United States
  • Loma Linda University Health — Loma Linda, California, United States
  • Long Beach Research Institute — Long Beach, California, United States
  • Ace Research Institute - Monterey Park — Monterey Park, California, United States
  • Amicis Research: Newhall — Newhall, California, United States
  • Ace Research Institute: Northridge — Northridge, California, United States
  • Amicis Research: Northridge — Northridge, California, United States
  • Ace Research Institute: Northridge #2 — Northridge, California, United States
  • Northridge Clinical Trials — Northridge, California, United States
  • University of California- Irvine — Orange, California, United States
  • Stanford Health Care — Palo Alto, California, United States
  • VA Palo Alto — Palo Alto, California, United States
  • Amicis Research: San Fernando — San Fernando, California, United States
  • Valiance Clinical Research - Tarzana — Tarzana, California, United States
  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center — Torrance, California, United States
  • Amicis Research: Valencia — Valencia, California, United States
  • Concierge Clinical Trials — Valley Village, California, United States
  • University of Colorado — Aurora, Colorado, United States
  • St. Josephs (Intermountain Healthcare) — Denver, Colorado, United States
  • Flourish Medical Research — Boca Raton, Florida, United States
  • Apex Research — Cross City, Florida, United States
  • Evolution Research Center — Hialeah, Florida, United States
  • UF Health Jacksonville — Jacksonville, Florida, United States
  • Fiel Wellness Clinical Research LLC — Miami, Florida, United States
  • BioPhase Research — Miami, Florida, United States
  • United Clinical Research — Miami, Florida, United States
  • Atlantis Clinical Research, LLC — Miami, Florida, United States
  • Baptist Health Miami Cardiac and Vascular Institute — Miami, Florida, United States
  • Farma Medical Inc. — Miami, Florida, United States
  • New Access Research and Medical Center — Miami, Florida, United States
  • Quantum Clinical Trials — Miami Beach, Florida, United States
  • Ascension Sacred Heart — Pensacola, Florida, United States
  • Clinical Research Center of Florida — Pompano Beach, Florida, United States
  • University of South Florida — Tampa, Florida, United States
  • Aiyan Diabetes Center — Augusta, Georgia, United States
  • Emory University — Dunwoody, Georgia, United States
  • Privia Medical Group Georgia LLC -Fayetteville (Javara) — Fayetteville, Georgia, United States
  • Randomize Now- Atlanta West — Lithia Springs, Georgia, United States
  • Randomize Now-Burton Medical — Macon, Georgia, United States
  • Evergreen Clinical Trials — Norcross, Georgia, United States
  • Peachtree Clinical Solutions - Noir Research Collective — Powder Springs, Georgia, United States
  • Randomize Now, LLC - Noir Research Collective — Riverdale, Georgia, United States
  • Privia Medical Group Georgia, LLC (Javara Inc.) — Savannah, Georgia, United States
  • Privia Medical Group Georgia - Thomasville (Javara) — Thomasville, Georgia, United States
  • Care Institute- High Desert — Meridian, Idaho, United States
  • Northwestern University — Chicago, Illinois, United States
  • Northshore University Health System — Glenview, Illinois, United States
  • Indiana Medical Research Institute — Indianapolis, Indiana, United States
  • Franciscan Physician Network- Indiana Heart Physicians — Indianapolis, Indiana, United States
  • MercyOne Iowa Heart Center — West Des Moines, Iowa, United States
  • St Elizabeth Health Care - CRI — Edgewood, Kentucky, United States
  • UofL Health — Louisville, Kentucky, United States
  • Ascension DePaul Services Research Center — New Orleans, Louisiana, United States
  • Flourish Bowie dba Flourish Research — Bowie, Maryland, United States
  • KUR Research at CMP — Columbia, Maryland, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • Brigham and Women's Hospital — Boston, Massachusetts, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Trinity Health Michigan Heart — Ypsilanti, Michigan, United States
  • Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Saint Louis Heart and Vascular — St Louis, Missouri, United States
  • Boeson Research Kalispell — Kalispell, Montana, United States
  • Boeson Research Fort Missoula — Missoula, Montana, United States
  • Bryan Heart — Lincoln, Nebraska, United States
  • Southwest Medical Associates- Optum Nevada — Las Vegas, Nevada, United States
  • Vector Clinical Trials — Las Vegas, Nevada, United States
  • Advanced Heart and Vascular Institute of Hunterdon — Flemington, New Jersey, United States
  • Virtua Health, Inc. — Marlton, New Jersey, United States
  • Rutgers State University — New Brunswick, New Jersey, United States
  • The Valley Hospital — Paramus, New Jersey, United States
  • Holy Name Medical Center — Teaneck, New Jersey, United States
  • Clindove Research — Brooklyn, New York, United States
  • Swift Clinical Research — Brooklyn, New York, United States
  • Rasaj Research — Jackson Heights, New York, United States
  • Optum- Long Island NY — Lake Success, New York, United States
  • Northwell Health Northern Westchester Hospital — Mount Kisco, New York, United States
  • Mount Sinai West — New York, New York, United States
  • Mount Sinai — New York, New York, United States
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
  • Duke University Hospital — Durham, North Carolina, United States
  • Durham Veterans Affairs Medical Center (Durham VAMC) — Durham, North Carolina, United States
  • Cape Fear Valley Health System (Javara Inc.) — Fayetteville, North Carolina, United States
  • West Clinical Research — Morehead City, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Sanford Health — Fargo, North Dakota, United States
  • Summa Health — Akron, Ohio, United States
  • Hightower Clinical — Oklahoma City, Oklahoma, United States
  • Medical Research International, LLC — Oklahoma City, Oklahoma, United States
  • Ascension St. John - Jane Phillips Medical Center — Tulsa, Oklahoma, United States
  • Capital Area Research — Camp Hill, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Community DPC — Cleveland, Tennessee, United States
  • University of Tennessee Medical Center — Knoxville, Tennessee, United States
  • TriStar Centennial Medical Center (HCA Health Care) — Nashville, Tennessee, United States
  • Hendrick Health — Abilene, Texas, United States
  • Gadolin Research — Beaumont, Texas, United States
  • CardioVoyage, LLC — Greenville, Texas, United States
  • Helium Research Group — Houston, Texas, United States
  • Kelsey Research Foundation — Houston, Texas, United States
  • The Methodist Hospital, DeBakey Cardiology Associates — Houston, Texas, United States
  • Gulf Coast Clinical Research, LLC — Houston, Texas, United States
  • Aeres Clinical Research — Laredo, Texas, United States
  • DC Clinical Research — Lewisville, Texas, United States
  • North Dallas Research Associates - Kerlo Network — McKinney, Texas, United States
  • SMS Clinical Research — Mesquite, Texas, United States
  • Privia Medical Group Gulf Coast, PLLC ( Javara Inc.) — San Marcos, Texas, United States
  • Privia Medical Group- North Texas — Stephenville, Texas, United States
  • Kalo Clinical Research — West Valley City, Utah, United States
  • Chippenham Johnston Willis Medical Center — Richmond, Virginia, United States
  • Providence Regional Medical Center Everett — Everett, Washington, United States
  • University of Washington — Seattle, Washington, United States
  • Charleston Area Medical Center — Charleston, West Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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