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

NCT06112418

This study is recruiting at 122 US sites in 32 states, according to its ClinicalTrials.gov record last updated .

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Metabolic Syndrome

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
55 years and older
Sex
All
Healthy volunteers
Accepted
Sponsor
Cleerly, Inc.
Last updated on ClinicalTrials.gov
September 28, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 4

  • Chandler Clinical Trials · Chandler, AZ
  • Scottsdale Clinical Trials · Scottsdale, AZ
  • Sun City Research · Sun City, AZ
  • Noble Clinical Research · Tucson, AZ

California · 24

  • Amicis Research: Beverly Hills · Beverly Hills, CA
  • Cardiovascular Research Foundation of Southern California · Beverly Hills, CA
  • Valiance Clinical Research - Canoga Park · Canoga Park, CA
  • Cardiovascular Institute of San Diego · Chula Vista, CA
  • Amicis Research: Granada Hills · Granada Hills, CA
  • Valiance Clinical Research: Huntington Park · Huntington Park, CA
  • HALO Diagnostics · Indian Wells, CA
  • Scripps Health · La Jolla, CA
  • Chemidox Clinical Trials · Lancaster, CA
  • Loma Linda University Health · Loma Linda, CA
  • Long Beach Research Institute · Long Beach, CA
  • Ace Research Institute - Monterey Park · Monterey Park, CA
  • Amicis Research: Newhall · Newhall, CA
  • Ace Research Institute: Northridge · Northridge, CA
  • Ace Research Institute: Northridge #2 · Northridge, CA
  • Amicis Research: Northridge · Northridge, CA
  • University of California- Irvine · Orange, CA
  • Stanford Health Care · Palo Alto, CA
  • VA Palo Alto · Palo Alto, CA
  • Amicis Research: San Fernando · San Fernando, CA
  • Valiance Clinical Research - Tarzana · Tarzana, CA
  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center · Torrance, CA
  • Amicis Research: Valencia · Valencia, CA
  • Concierge Clinical Trials · Valley Village, CA

Colorado · 2

  • University of Colorado · Aurora, CO
  • St. Josephs (Intermountain Healthcare) · Denver, CO

Florida · 15

  • Flourish Medical Research · Boca Raton, FL
  • Apex Research · Cross City, FL
  • Evolution Research Center · Hialeah, FL
  • UF Health Jacksonville · Jacksonville, FL
  • Atlantis Clinical Research, LLC · Miami, FL
  • Baptist Health Miami Cardiac and Vascular Institute · Miami, FL
  • BioPhase Research · Miami, FL
  • Farma Medical Inc. · Miami, FL
  • Fiel Wellness Clinical Research LLC · Miami, FL
  • New Access Research and Medical Center · Miami, FL
  • United Clinical Research · Miami, FL
  • Quantum Clinical Trials · Miami Beach, FL
  • Ascension Sacred Heart · Pensacola, FL
  • Clinical Research Center of Florida · Pompano Beach, FL
  • University of South Florida · Tampa, FL

Georgia · 10

  • Aiyan Diabetes Center · Augusta, GA
  • Emory University · Dunwoody, GA
  • Privia Medical Group Georgia LLC -Fayetteville (Javara) · Fayetteville, GA
  • Randomize Now- Atlanta West · Lithia Springs, GA
  • Randomize Now-Burton Medical · Macon, GA
  • Evergreen Clinical Trials · Norcross, GA
  • Peachtree Clinical Solutions - Noir Research Collective · Powder Springs, GA
  • Randomize Now, LLC - Noir Research Collective · Riverdale, GA
  • Privia Medical Group Georgia, LLC (Javara Inc.) · Savannah, GA
  • Privia Medical Group Georgia - Thomasville (Javara) · Thomasville, GA

Idaho · 1

  • Care Institute- High Desert · Meridian, ID

Illinois · 2

  • Northwestern University · Chicago, IL
  • Northshore University Health System · Glenview, IL

Indiana · 2

  • Franciscan Physician Network- Indiana Heart Physicians · Indianapolis, IN
  • Indiana Medical Research Institute · Indianapolis, IN

Iowa · 1

  • MercyOne Iowa Heart Center · West Des Moines, IA

Kentucky · 2

  • St Elizabeth Health Care - CRI · Edgewood, KY
  • UofL Health · Louisville, KY

Louisiana · 1

  • Ascension DePaul Services Research Center · New Orleans, LA

Maryland · 2

  • Flourish Bowie dba Flourish Research · Bowie, MD
  • KUR Research at CMP · Columbia, MD

Massachusetts · 2

  • Brigham and Women's Hospital · Boston, MA
  • Massachusetts General Hospital · Boston, MA

Michigan · 2

  • Henry Ford Hospital · Detroit, MI
  • Trinity Health Michigan Heart · Ypsilanti, MI

Minnesota · 1

  • Minneapolis Heart Institute Foundation · Minneapolis, MN

Missouri · 2

  • Saint Louis Heart and Vascular · St Louis, MO
  • Washington University School of Medicine · St Louis, MO

Montana · 2

  • Boeson Research Kalispell · Kalispell, MT
  • Boeson Research Fort Missoula · Missoula, MT

Nebraska · 1

  • Bryan Heart · Lincoln, NE

Nevada · 2

  • Southwest Medical Associates- Optum Nevada · Las Vegas, NV
  • Vector Clinical Trials · Las Vegas, NV

New Jersey · 5

  • Advanced Heart and Vascular Institute of Hunterdon · Flemington, NJ
  • Virtua Health, Inc. · Marlton, NJ
  • Rutgers State University · New Brunswick, NJ
  • The Valley Hospital · Paramus, NJ
  • Holy Name Medical Center · Teaneck, NJ

New York · 7

  • Clindove Research · Brooklyn, NY
  • Swift Clinical Research · Brooklyn, NY
  • Rasaj Research · Jackson Heights, NY
  • Optum- Long Island NY · Lake Success, NY
  • Northwell Health Northern Westchester Hospital · Mount Kisco, NY
  • Mount Sinai · New York, NY
  • Mount Sinai West · New York, NY

North Carolina · 5

  • University of North Carolina at Chapel Hill · Chapel Hill, NC
  • Duke University Hospital · Durham, NC
  • Durham Veterans Affairs Medical Center (Durham VAMC) · Durham, NC
  • Cape Fear Valley Health System (Javara Inc.) · Fayetteville, NC
  • Wake Forest University Health Sciences · Winston-Salem, NC

North Dakota · 1

  • Sanford Health · Fargo, ND

Ohio · 1

  • Summa Health · Akron, OH

Oklahoma · 3

  • Hightower Clinical · Oklahoma City, OK
  • Medical Research International, LLC · Oklahoma City, OK
  • Ascension St. John - Jane Phillips Medical Center · Tulsa, OK

Pennsylvania · 1

  • Capital Area Research · Camp Hill, PA

South Carolina · 1

  • Medical University of South Carolina · Charleston, SC

Tennessee · 3

  • Community DPC · Cleveland, TN
  • University of Tennessee Medical Center · Knoxville, TN
  • TriStar Centennial Medical Center (HCA Health Care) · Nashville, TN

Texas · 13

  • Hendrick Health · Abilene, TX
  • Gadolin Research · Beaumont, TX
  • CardioVoyage, LLC · Greenville, TX
  • Gulf Coast Clinical Research, LLC · Houston, TX
  • Helium Research Group · Houston, TX
  • Kelsey Research Foundation · Houston, TX
  • The Methodist Hospital, DeBakey Cardiology Associates · Houston, TX
  • Aeres Clinical Research · Laredo, TX
  • DC Clinical Research · Lewisville, TX
  • North Dallas Research Associates - Kerlo Network · McKinney, TX
  • SMS Clinical Research · Mesquite, TX
  • Privia Medical Group Gulf Coast, PLLC ( Javara Inc.) · San Marcos, TX
  • Privia Medical Group- North Texas · Stephenville, TX

Virginia · 1

  • Chippenham Johnston Willis Medical Center · Richmond, VA

Washington · 2

  • Providence Regional Medical Center Everett · Everett, WA
  • University of Washington · Seattle, WA

West Virginia · 1

  • Charleston Area Medical Center · Charleston, WV

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.