A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
TRANSFORM
A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events
1 other identifier
interventional
7,500
1 country
123
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2024
Longer than P75 for not_applicable diabetes-mellitus-type-2
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedStudy Start
First participant enrolled
March 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 5, 2029
April 14, 2026
April 1, 2026
5 years
October 2, 2023
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.
The primary endpoint is total (first and subsequent) events for the composite endpoint of CV death, myocardial infarction (MI), ischemic stroke, acute limb ischemia, clinically driven arterial revascularization, and hospitalization or urgent visit for heart failure.
Through study completion- an average of 3.5 years
Secondary Outcomes (5)
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.
Through study completion- an average of 3.5 years
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.
Through study completion- an average of 3.5 years
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.
Through study completion- an average of 3.5 years
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.
Through study completion- an average of 3.5 years
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.
Through study completion- an average of 3.5 years
Other Outcomes (2)
The safety objective is to assess harm with the 2 prevention strategies
Through study completion- an average of 3.5 years
The safety objective is to assess harm with the 2 prevention strategies
Through study completion- an average of 3.5 years
Study Arms (2)
Risk Factor-Based Care
NO INTERVENTIONThe 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.
Cleerly Stage-Based Care
EXPERIMENTALThe 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.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
- Planned arterial revascularization
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CPC Clinical Researchcollaborator
- Cleerly, Inc.lead
Study Sites (123)
Chandler Clinical Trials
Chandler, Arizona, 85224, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Sun City Research
Sun City, Arizona, 85381, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, 90210, United States
Amicis Research: Beverly Hills
Beverly Hills, California, 90211, United States
Valiance Clinical Research - Canoga Park
Canoga Park, California, 91303, United States
Cardiovascular Institute of San Diego
Chula Vista, California, 91911, United States
Amicis Research: Granada Hills
Granada Hills, California, 91324, United States
Valiance Clinical Research: Huntington Park
Huntington Park, California, 90255, United States
HALO Diagnostics
Indian Wells, California, 92210, United States
Scripps Health
La Jolla, California, 92037, United States
Chemidox Clinical Trials
Lancaster, California, 93534, United States
Long Beach Research Institute
Long Beach, California, 90805, United States
Ace Research Institute - Monterey Park
Monterey Park, California, 91754, United States
Amicis Research: Newhall
Newhall, California, 91321, United States
Ace Research Institute: Northridge
Northridge, California, 91324, United States
Amicis Research: Northridge
Northridge, California, 91324, United States
Ace Research Institute: Northridge #2
Northridge, California, 91325, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
University of California- Irvine
Orange, California, 92868, United States
Stanford Health Care
Palo Alto, California, 94304, United States
VA Palo Alto
Palo Alto, California, 94304, United States
Amicis Research: San Fernando
San Fernando, California, 91306, United States
Valiance Clinical Research - Tarzana
Tarzana, California, 91356, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, 90502, United States
Amicis Research: Valencia
Valencia, California, 91355, United States
Concierge Clinical Trials
Valley Village, California, 91607, United States
University of Colorado
Aurora, Colorado, 80045, United States
St. Josephs (Intermountain Healthcare)
Denver, Colorado, 80218, United States
Flourish Medical Research
Boca Raton, Florida, 33434, United States
Apex Research
Cross City, Florida, 32628, United States
Evolution Research Center
Hialeah, Florida, 33012, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Fiel Wellness Clinical Research LLC
Miami, Florida, 33135, United States
BioPhase Research
Miami, Florida, 33137, United States
United Clinical Research
Miami, Florida, 33155, United States
Atlantis Clinical Research, LLC
Miami, Florida, 33173, United States
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, 33173, United States
Farma Medical Inc.
Miami, Florida, 33183, United States
New Access Research and Medical Center
Miami, Florida, 33186, United States
Quantum Clinical Trials
Miami Beach, Florida, 33140, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
University of South Florida
Tampa, Florida, 33620, United States
Aiyan Diabetes Center
Augusta, Georgia, 30907, United States
Emory University
Dunwoody, Georgia, 30338, United States
Privia Medical Group Georgia LLC -Fayetteville (Javara)
Fayetteville, Georgia, 30214, United States
Randomize Now- Atlanta West
Lithia Springs, Georgia, 30122, United States
Randomize Now-Burton Medical
Macon, Georgia, 31210, United States
Evergreen Clinical Trials
Norcross, Georgia, 30092, United States
Peachtree Clinical Solutions - Noir Research Collective
Powder Springs, Georgia, 30127, United States
Randomize Now, LLC - Noir Research Collective
Riverdale, Georgia, 30296, United States
Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah, Georgia, 31406, United States
Privia Medical Group Georgia - Thomasville (Javara)
Thomasville, Georgia, 31792, United States
Care Institute- High Desert
Meridian, Idaho, 83642, United States
Northwestern University
Chicago, Illinois, 60611, United States
Northshore University Health System
Glenview, Illinois, 60026, United States
Indiana Medical Research Institute
Indianapolis, Indiana, 46202, United States
Franciscan Physician Network- Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50266, United States
St Elizabeth Health Care - CRI
Edgewood, Kentucky, 41017, United States
UofL Health
Louisville, Kentucky, 40202, United States
Flourish Bowie dba Flourish Research
Bowie, Maryland, 20715, United States
KUR Research at CMP
Columbia, Maryland, 21045, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48917, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Saint Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Boeson Research Kalispell
Kalispell, Montana, 59901, United States
Boeson Research Fort Missoula
Missoula, Montana, 59804, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
Southwest Medical Associates- Optum Nevada
Las Vegas, Nevada, 89102, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822, United States
Virtua Health, Inc.
Marlton, New Jersey, 08053, United States
Rutgers State University
New Brunswick, New Jersey, 08901, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Clindove Research
Brooklyn, New York, 11221, United States
Swift Clinical Research
Brooklyn, New York, 11226, United States
Rasaj Research
Jackson Heights, New York, 11372, United States
Optum- Long Island NY
Lake Success, New York, 11042, United States
Northwell Health Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Hospital
Durham, North Carolina, 27701, United States
Durham Veterans Affairs Medical Center (Durham VAMC)
Durham, North Carolina, 27705, United States
Cape Fear Valley Health System (Javara Inc.)
Fayetteville, North Carolina, 28304, United States
West Clinical Research
Morehead City, North Carolina, 28557, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Health
Fargo, North Dakota, 58102, United States
Summa Health
Akron, Ohio, 44304, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73007, United States
Medical Research International, LLC
Oklahoma City, Oklahoma, 73109, United States
Ascension St. John - Jane Phillips Medical Center
Tulsa, Oklahoma, 74104, United States
Capital Area Research
Camp Hill, Pennsylvania, 17011, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Community DPC
Cleveland, Tennessee, 37312, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
TriStar Centennial Medical Center (HCA Health Care)
Nashville, Tennessee, 37202, United States
Hendrick Health
Abilene, Texas, 79601, United States
Gadolin Research
Beaumont, Texas, 77702, United States
CardioVoyage, LLC
Greenville, Texas, 75402, United States
Helium Research Group
Houston, Texas, 77004, United States
Kelsey Research Foundation
Houston, Texas, 77025, United States
The Methodist Hospital, DeBakey Cardiology Associates
Houston, Texas, 77030, United States
Gulf Coast Clinical Research, LLC
Houston, Texas, 77070, United States
Aeres Clinical Research
Laredo, Texas, 78041, United States
DC Clinical Research
Lewisville, Texas, 75057, United States
North Dallas Research Associates - Kerlo Network
McKinney, Texas, 75069, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
San Marcos, Texas, 78666, United States
Privia Medical Group- North Texas
Stephenville, Texas, 76401, United States
Kalo Clinical Research
West Valley City, Utah, 84120, United States
Chippenham Johnston Willis Medical Center
Richmond, Virginia, 23225, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
University of Washington
Seattle, Washington, 98195, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Related Publications (2)
Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PMID: 35078371BACKGROUNDClerc OF, Fuchs TA, Stehli J, Benz DC, Grani C, Messerli M, Giannopoulos AA, Buechel RR, Luscher TF, Pazhenkottil AP, Kaufmann PA, Gaemperli O. Non-invasive screening for coronary artery disease in asymptomatic diabetic patients: a systematic review and meta-analysis of randomised controlled trials. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):838-846. doi: 10.1093/ehjci/jey014.
PMID: 29452348BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Deepak Bhatt, MD, MPH
Mt. Sinai Heart
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2023
First Posted
November 1, 2023
Study Start
March 6, 2024
Primary Completion (Estimated)
March 5, 2029
Study Completion (Estimated)
March 5, 2029
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share