Testing a Heart Scan Staging System to Guide Care for Heart Disease Risk
Tests a heart scan staging tool to guide care in adults with diabetes or prediabetes.
Plain-language title generated from the registry record
Registry title: A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
Key facts
- Where
- Abilene, Akron, Augusta, Aurora, Beaumont, Beverly Hills, Boca Raton, Boston, Bowie, Brooklyn, Camp Hill, Canoga Park, Chandler, Chapel Hill, Charleston, Chicago, Chula Vista, Cleveland, Columbia, Cross City, Denver, Detroit, Dunwoody, Durham, Edgewood, Everett, Fargo, Fayetteville, Flemington, Glenview, Granada Hills, Greenville, Hialeah, Houston, Huntington Park, Indian Wells, Indianapolis, Jackson Heights, Jacksonville, Kalispell, Knoxville, La Jolla, Lake Success, Lancaster, Laredo, Las Vegas, Lewisville, Lincoln, Lithia Springs, Loma Linda, Long Beach, Louisville, Macon, Marlton, McKinney, Meridian, Mesquite, Miami, Miami Beach, Minneapolis, Missoula, Monterey Park, Morehead City, Mount Kisco, Nashville, New Brunswick, New Orleans, New York, Newhall, Norcross, Northridge, Oklahoma City, Orange, Palo Alto, Paramus, Pensacola, Pompano Beach, Powder Springs, Richmond, Riverdale, San Fernando, San Marcos, Savannah, Scottsdale, Seattle, St Louis, Stephenville, Sun City, Tampa, Tarzana, Teaneck, Thomasville, Torrance, Tucson, Tulsa, Valencia, Valley Village, West Des Moines, West Valley City, Winston-Salem, and Ypsilanti, United StatesSee the 125 sites
Where in United States
- Hendrick HealthAbilene, United StatesTaking people
- Summa HealthAkron, United StatesTaking people
- Aiyan Diabetes CenterAugusta, United StatesTaking people
- University of ColoradoAurora, United StatesTaking people
- Gadolin ResearchBeaumont, United StatesTaking people
- Amicis Research: Beverly HillsBeverly Hills, United StatesTaking people
- Cardiovascular Research Foundation of Southern CaliforniaBeverly Hills, United StatesTaking people
- Flourish Medical ResearchBoca Raton, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Flourish Bowie dba Flourish ResearchBowie, United StatesTaking people
- Clindove ResearchBrooklyn, United StatesTaking people
- Swift Clinical ResearchBrooklyn, United StatesTaking people
- Capital Area ResearchCamp Hill, United StatesTaking people
- Valiance Clinical Research - Canoga ParkCanoga Park, United StatesTaking people
- Chandler Clinical TrialsChandler, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Charleston Area Medical CenterCharleston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Cardiovascular Institute of San DiegoChula Vista, United StatesTaking people
- Community DPCCleveland, United StatesTaking people
- KUR Research at CMPColumbia, United StatesTaking people
- Apex ResearchCross City, United StatesTaking people
- St. Josephs (Intermountain Healthcare)Denver, United StatesTaking people
- Henry Ford HospitalDetroit, United StatesTaking people
- Emory UniversityDunwoody, United StatesTaking people
- Duke University HospitalDurham, United StatesTaking people
- Durham Veterans Affairs Medical Center (Durham VAMC)Durham, United StatesTaking people
- St Elizabeth Health Care - CRIEdgewood, United StatesTaking people
- Providence Regional Medical Center EverettEverett, United StatesTaking people
- Sanford HealthFargo, United StatesTaking people
- Cape Fear Valley Health System (Javara Inc.)Fayetteville, United StatesTaking people
- Privia Medical Group Georgia LLC -Fayetteville (Javara)Fayetteville, United StatesTaking people
- Advanced Heart and Vascular Institute of HunterdonFlemington, United StatesTaking people
- Northshore University Health SystemGlenview, United StatesTaking people
- Amicis Research: Granada HillsGranada Hills, United StatesTaking people
- CardioVoyage, LLCGreenville, United StatesTaking people
- Evolution Research CenterHialeah, United StatesTaking people
- Gulf Coast Clinical Research, LLCHouston, United StatesTaking people
- Helium Research GroupHouston, United StatesTaking people
- Kelsey Research FoundationHouston, United StatesTaking people
- The Methodist Hospital, DeBakey Cardiology AssociatesHouston, United StatesTaking people
- Valiance Clinical Research: Huntington ParkHuntington Park, United StatesTaking people
- HALO DiagnosticsIndian Wells, United StatesTaking people
- Franciscan Physician Network, Indiana Heart PhysiciansIndianapolis, United StatesTaking people
- Indiana Medical Research InstituteIndianapolis, United StatesTaking people
- Rasaj ResearchJackson Heights, United StatesTaking people
- UF Health JacksonvilleJacksonville, United StatesTaking people
- Boeson Research KalispellKalispell, United StatesTaking people
- University of Tennessee Medical CenterKnoxville, United StatesTaking people
- Scripps HealthLa Jolla, United StatesTaking people
- Optum- Long Island NYLake Success, United StatesTaking people
- Chemidox Clinical TrialsLancaster, United StatesTaking people
- Aeres Clinical ResearchLaredo, United StatesTaking people
- Southwest Medical Associates- Optum NevadaLas Vegas, United StatesTaking people
- Vector Clinical TrialsLas Vegas, United StatesTaking people
- DC Clinical ResearchLewisville, United StatesTaking people
- Bryan HeartLincoln, United StatesTaking people
- Randomize Now- Atlanta WestLithia Springs, United StatesTaking people
- Loma Linda University HealthLoma Linda, United StatesTaking people
- Long Beach Research InstituteLong Beach, United StatesTaking people
- UofL HealthLouisville, United StatesTaking people
- Randomize Now-Burton MedicalMacon, United StatesTaking people
- Virtua Health IncMarlton, United StatesTaking people
- North Dallas Research Associates - Kerlo NetworkMcKinney, United StatesTaking people
- Care Institute- High DesertMeridian, United StatesTaking people
- SMS Clinical ResearchMesquite, United StatesTaking people
- Atlantis Clinical Research, LLCMiami, United StatesTaking people
- Baptist Health Miami Cardiac and Vascular InstituteMiami, United StatesTaking people
- BioPhase ResearchMiami, United StatesTaking people
- Farma Medical Inc.Miami, United StatesTaking people
- Fiel Wellness Clinical Research LLCMiami, United StatesTaking people
- New Access Research and Medical CenterMiami, United StatesTaking people
- United Clinical ResearchMiami, United StatesTaking people
- Quantum Clinical TrialsMiami Beach, United StatesTaking people
- Minneapolis Heart Institute FoundationMinneapolis, United StatesTaking people
- Boeson Research Fort MissoulaMissoula, United StatesTaking people
- Ace Research Institute - Monterey ParkMonterey Park, United StatesTaking people
- West Clinical ResearchMorehead City, United StatesNo longer taking part
- Northwell Health Northern Westchester HospitalMount Kisco, United StatesTaking people
- TriStar Centennial Medical Center (HCA Health Care)Nashville, United StatesTaking people
- Rutgers State UniversityNew Brunswick, United StatesTaking people
- Ascension DePaul Services Research CenterNew Orleans, United StatesTaking people
- Mount SinaiNew York, United StatesTaking people
- Mount Sinai WestNew York, United StatesTaking people
- Amicis Research: NewhallNewhall, United StatesTaking people
- Evergreen Clinical TrialsNorcross, United StatesTaking people
- Ace Research Institute: NorthridgeNorthridge, United StatesTaking people
- Ace Research Institute: Northridge #2Northridge, United StatesTaking people
- Amicis Research: NorthridgeNorthridge, United StatesTaking people
- Northridge Clinical TrialsNorthridge, United StatesNo longer taking part
- Hightower ClinicalOklahoma City, United StatesTaking people
- Medical Research International, LLCOklahoma City, United StatesTaking people
- University of California IrvineOrange, United StatesTaking people
- Stanford Health CarePalo Alto, United StatesTaking people
- VA Palo AltoPalo Alto, United StatesTaking people
- The Valley HospitalParamus, United StatesTaking people
- Ascension Sacred HeartPensacola, United StatesTaking people
- Clinical Research Center of FloridaPompano Beach, United StatesTaking people
- Peachtree Clinical Solutions - Noir Research CollectivePowder Springs, United StatesTaking people
- Chippenham Johnston Willis Medical CenterRichmond, United StatesTaking people
- Randomize Now, LLC - Noir Research CollectiveRiverdale, United StatesTaking people
- Amicis Research: San FernandoSan Fernando, United StatesTaking people
- Privia Medical Group Gulf Coast, PLLC (Javara Inc.)San Marcos, United StatesTaking people
- Privia Medical Group Georgia, LLC (Javara Inc.)Savannah, United StatesTaking people
- Scottsdale Clinical TrialsScottsdale, United StatesTaking people
- University of WashingtonSeattle, United StatesTaking people
- Saint Louis Heart and VascularSt Louis, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- Privia Medical Group- North TexasStephenville, United StatesTaking people
- Sun City ResearchSun City, United StatesTaking people
- University of South FloridaTampa, United StatesTaking people
- Valiance Clinical Research - TarzanaTarzana, United StatesTaking people
- Holy Name Medical CenterTeaneck, United StatesTaking people
- Privia Medical Group Georgia - Thomasville (Javara)Thomasville, United StatesTaking people
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesTaking people
- Noble Clinical ResearchTucson, United StatesTaking people
- Ascension St. John - Jane Phillips Medical CenterTulsa, United StatesTaking people
- Amicis Research: ValenciaValencia, United StatesTaking people
- Concierge Clinical TrialsValley Village, United StatesTaking people
- MercyOne Iowa Heart CenterWest Des Moines, United StatesTaking people
- Kalo Clinical ResearchWest Valley City, United StatesNot yet recruiting
- Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
- Trinity Health Michigan HeartYpsilanti, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cleerly, Inc.
- Trial code
- NCT06112418
- Record updated
- 28 September 2026
- Original 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.Read full original descriptionShow less
A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events
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.
Inclusion: Provided electronic or written informed consent; Men > 55, women > 65 years of age; 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%; 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: 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; Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:; 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); 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; Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment; Weight > 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site; Inability to hold breath for > 10 seconds; 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); Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA; Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA; 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); Planned arterial revascularization.