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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two ways to prevent heart and blood vessel problems: care based on the stage of heart artery disease and care based on risk factors. It is for older adults at higher risk who have no known heart or blood vessel disease causing symptoms.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Give written or electronic consent to join.
- Be a man older than 55 or a woman older than 65.
- Have type 2 diabetes treated with medicine, prediabetes, or metabolic syndrome.
- Prediabetes means a recent HbA1c of 5.7–6.4% or fasting blood sugar of 100–125 mg/dL. HbA1c measures average blood sugar.
- Metabolic syndrome means having more than 3 of these: high body weight or waist size, high blood fats called triglycerides, low HDL ('good') cholesterol, high blood pressure, or high blood sugar. Study-specific limits apply.
- Have a smartphone, tablet, or computer to contact the heart care team that manages medicines for the personalized care group.
Who can't join
- Past heart attack, chest pain from heart disease, stroke from a blocked blood vessel, or leg pain from poor blood flow. Other heart disease being treated by a heart doctor, such as an irregular heartbeat or heart failure, also rules you out.
- Past artery-opening treatment for plaque buildup, or a planned procedure to restore blood flow through an artery.
- Cannot safely complete a CCTA—a CT scan of the heart arteries—or are likely to have a scan that cannot be read clearly.
- Kidney filtering test (eGFR) below 60, allergy to iodine-based scan dye, or past kidney damage from scan dye.
- Untreated overactive thyroid, thyroid cancer within the past 5 years, or planned radioactive iodine treatment.
- Weight over 300 pounds or the scanner's weight limit, or inability to hold your breath for more than 10 seconds.
- An active irregular heartbeat with a poorly controlled rate above 80 beats per minute, or inability to safely take a beta blocker or nitroglycerin on scan day.
- The study doctor finds participation unsuitable, such as severe narrowing of the main heart artery, another illness with expected survival under 3 years, or likely trouble following study steps.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (125)
AZ
- Chandler Clinical Trials · Chandler, AZ 85224Muhammad Salim, MD · Study contactMore trials in Chandler
- Scottsdale Clinical Trials · Scottsdale, AZ 85260Todd Dreitzler, MD · Study contactMore trials in Scottsdale
- Sun City Research · Sun City, AZ 85381Juan Rodriguez, MD · Study contactMore trials in Sun City
- Noble Clinical Research · Tucson, AZ 85704Roxana Rodriguez, MD · Study contactMore trials in Tucson
CA
- Cardiovascular Research Foundation of Southern California · Beverly Hills, CA 90210Ronald P. Karlsberg, MD · Study contactMore trials in Beverly Hills
- Amicis Research: Beverly Hills · Beverly Hills, CA 90211Michael Levine, MD · Study contactMore trials in Beverly Hills
- Valiance Clinical Research - Canoga Park · Canoga Park, CA 91303Rami Shaarawy · Study contactMore trials in Canoga Park
- Cardiovascular Institute of San Diego · Chula Vista, CA 91911Milind D. Parikh, MD · Study contactMore trials in Chula Vista
- Amicis Research: Granada Hills · Granada Hills, CA 91324Pascal Dabel, MD · Study contactMore trials in Granada Hills
- Valiance Clinical Research: Huntington Park · Huntington Park, CA 90255Philip Kim, MD · Study contactMore trials in Huntington Park
- HALO Diagnostics · Indian Wells, CA 92210John F. Feller, MD · Study contactMore trials in Indian Wells
- Scripps Health · La Jolla, CA 92037Elizabeth Epstein, MD · Study contactMore trials in La Jolla
- Chemidox Clinical Trials · Lancaster, CA 93534Pamela Dewar-DeSilva, MD · Study contactMore trials in Lancaster
- Loma Linda University Health · Loma Linda, CA 92354Purvi Parwani, MD · Study contactMore trials in Loma Linda
- Long Beach Research Institute · Long Beach, CA 90805Ashley Duzik, MD · Study contactMore trials in Long Beach
- Ace Research Institute - Monterey Park · Monterey Park, CA 91754Yu-Hsiang Sam Lee, MD · Study contactMore trials in Monterey Park
- Amicis Research: Newhall · Newhall, CA 91321Thuong Vo, MD · Study contactMore trials in Newhall
- Ace Research Institute: Northridge · Northridge, CA 91324Richard Park, MD · Study contactMore trials in Northridge
- Amicis Research: Northridge · Northridge, CA 91324Nana Barseghian, MD · Study contactMore trials in Northridge
- Ace Research Institute: Northridge #2 · Northridge, CA 91325William Y. Josephson, MD · Study contactMore trials in Northridge
- Northridge Clinical Trials · Northridge, CA 91325More trials in Northridge
- University of California- Irvine · Orange, CA 92868Ailin Barseghian El-Farra, MD · Study contactMore trials in Orange
- Stanford Health Care · Palo Alto, CA 94304Sandra Tsai, MD · Study contactMore trials in Palo Alto
- VA Palo Alto · Palo Alto, CA 94304Shriram Nallamshetty, MD · Study contactMore trials in Palo Alto
- Amicis Research: San Fernando · San Fernando, CA 91306Farid Yasharpour, MD · Study contactMore trials in San Fernando
- Valiance Clinical Research - Tarzana · Tarzana, CA 91356Harpreet Singh, MD · Study contactMore trials in Tarzana
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center · Torrance, CA 90502Suvasini Lakshmanan, MD · Study contactMore trials in Torrance
- Amicis Research: Valencia · Valencia, CA 91355Dennis Lewis, MD · Study contactMore trials in Valencia
- Concierge Clinical Trials · Valley Village, CA 91607Neal R. Cutler, MD · Study contactMore trials in Valley Village
CO
- University of Colorado · Aurora, CO 80045Steve Simon · Study contactSteve Simon, MD · Principal investigatorMore trials in Aurora
- St. Josephs (Intermountain Healthcare) · Denver, CO 80218Christopher Angus, MD · Study contactMore trials in Denver
FL
- Flourish Medical Research · Boca Raton, FL 33434Michael Hafran, MD · Study contactMore trials in Boca Raton
- Apex Research · Cross City, FL 32628Tamir Salmani, MD · Study contactMore trials in Cross City
- Evolution Research Center · Hialeah, FL 33012Riquel Gonzalez, MD · Study contactMore trials in Hialeah
- UF Health Jacksonville · Jacksonville, FL 32209Luis Ortega Paz, MD · Study contactMore trials in Jacksonville
- Fiel Wellness Clinical Research LLC · Miami, FL 33135Osvaldo Caroma, MD · Study contactMore trials in Miami
- BioPhase Research · Miami, FL 33137Julie Cadet-Plassman, MD · Study contactMore trials in Miami
- United Clinical Research · Miami, FL 33155Teresa B. Alfonso, MD · Study contactAlfonso · Study contactMore trials in Miami
- Atlantis Clinical Research, LLC · Miami, FL 33173Leyvi Alvarado Miranda, MD · Study contactMore trials in Miami
- Baptist Health Miami Cardiac and Vascular Institute · Miami, FL 33173Jonathan Fialkow, MD · Study contactMore trials in Miami
- Farma Medical Inc. · Miami, FL 33183Ingrid Fernandez-Milian, MD · Study contactMore trials in Miami
- New Access Research and Medical Center · Miami, FL 33186Sander Fernandez, MD · Study contactMore trials in Miami
- Quantum Clinical Trials · Miami Beach, FL 33140Christopher A. Fayeghi, MD · Study contactMore trials in Miami Beach
- Ascension Sacred Heart · Pensacola, FL 32504Rohit Amin, MD · Study contactMore trials in Pensacola
- Clinical Research Center of Florida · Pompano Beach, FL 33060Howard S. Koch, MD · Study contactMore trials in Pompano Beach
- University of South Florida · Tampa, FL 33620Shone Almeida, MD · Study contactMore trials in Tampa
GA
- Aiyan Diabetes Center · Augusta, GA 30907Anthony D. Turner, MD · Study contactMore trials in Augusta
- Emory University · Dunwoody, GA 30338Ambar Kulshreshtha, MD · Study contactMore trials in Dunwoody
- Privia Medical Group Georgia LLC -Fayetteville (Javara) · Fayetteville, GA 30214Charlotte Grayson Mathis, MD · Study contactMore trials in Fayetteville
- Randomize Now- Atlanta West · Lithia Springs, GA 30122Millard Collier Jr., MD · Study contactMore trials in Lithia Springs
- Randomize Now-Burton Medical · Macon, GA 31210Frederick Burton, MD · Study contactMore trials in Macon
- Evergreen Clinical Trials · Norcross, GA 30092Dmitriy Pelishev, MD · Study contactMore trials in Norcross
- Peachtree Clinical Solutions - Noir Research Collective · Powder Springs, GA 30127Karan Raghavan, MD · Study contactMore trials in Powder Springs
- Randomize Now, LLC - Noir Research Collective · Riverdale, GA 30296Claire K. Willie, MD · Study contactMore trials in Riverdale
- Privia Medical Group Georgia, LLC (Javara Inc.) · Savannah, GA 31406Thomas G. Moriarity, MD · Study contactMore trials in Savannah
- Privia Medical Group Georgia - Thomasville (Javara) · Thomasville, GA 31792William L. Cooper, MD · Study contactMore trials in Thomasville
IA
- MercyOne Iowa Heart Center · West Des Moines, IA 50266Enrico L. Martin, MD · Study contactMore trials in West Des Moines
ID
- Care Institute- High Desert · Meridian, ID 83642David A. Hinchman, MD · Study contactMore trials in Meridian
IL
- Northwestern University · Chicago, IL 60611Paul C. Cremer, MD · Study contactMore trials in Chicago
- Northshore University Health System · Glenview, IL 60026Amit K. Pursnani, MD · Study contactMore trials in Glenview
IN
- Indiana Medical Research Institute · Indianapolis, IN 46202Arshad P. Malik · Study contactMore trials in Indianapolis
- Franciscan Physician Network- Indiana Heart Physicians · Indianapolis, IN 46237Ryan P Daly, MD · Study contactMore trials in Indianapolis
KY
- St Elizabeth Health Care - CRI · Edgewood, KY 41017Erica Pivato, MD · Study contactMore trials in Edgewood
- UofL Health · Louisville, KY 40202Shahab Ghafghazi, MD · Study contactMore trials in Louisville
LA
- Ascension DePaul Services Research Center · New Orleans, LA 70127Kristen Thomas, MD · Study contactMore trials in New Orleans
MA
- Massachusetts General Hospital · Boston, MA 02114Pradeep Natarajan, MD · Study contactMore trials in Boston
- Brigham and Women's Hospital · Boston, MA 02115Ron Blankstein, MD · Study contactMore trials in Boston
MD
- Flourish Bowie dba Flourish Research · Bowie, MD 20715Sara Collins, MD · Study contactMore trials in Bowie
- KUR Research at CMP · Columbia, MD 21045William Saway, MD · Study contactMore trials in Columbia
MI
- Henry Ford Hospital · Detroit, MI 48202Cori E Russell, MD · Study contactMore trials in Detroit
- Trinity Health Michigan Heart · Ypsilanti, MI 48917Ahmad Mizyed, MD · Study contactMore trials in Ypsilanti
MN
- Minneapolis Heart Institute Foundation · Minneapolis, MN 55407Michael D. Miedema, MD · Study contactMore trials in Minneapolis
MO
- Washington University School of Medicine · St Louis, MO 63110Farhan M. Katchi, MD · Study contactMore trials in St Louis
- Saint Louis Heart and Vascular · St Louis, MO 63136Gil Vardi, MD · Study contactMore trials in St Louis
MT
- Boeson Research Kalispell · Kalispell, MT 59901Justin Buls, MD · Study contactMore trials in Kalispell
- Boeson Research Fort Missoula · Missoula, MT 59804Audrey Remmers, MD · Study contactMore trials in Missoula
NC
- University of North Carolina at Chapel Hill · Chapel Hill, NC 27599Matthew Cavender, MD · Study contactMore trials in Chapel Hill
- Duke University Hospital · Durham, NC 27701William Yancy, MD · Study contactMore trials in Durham
- Durham Veterans Affairs Medical Center (Durham VAMC) · Durham, NC 27705Hayden Bosworth, MD · Study contactMore trials in Durham
- Cape Fear Valley Health System (Javara Inc.) · Fayetteville, NC 28304Nafisa Saleem, MD · Study contactMore trials in Fayetteville
- West Clinical Research · Morehead City, NC 28557More trials in Morehead City
- Wake Forest University Health Sciences · Winston-Salem, NC 27157Michael Shapiro, MD · Study contactMore trials in Winston-Salem
ND
- Sanford Health · Fargo, ND 58102David J. Clardy, MD · Study contactMore trials in Fargo
NE
- Bryan Heart · Lincoln, NE 68506Chad E. Travers, MD · Study contactMore trials in Lincoln
NJ
- Advanced Heart and Vascular Institute of Hunterdon · Flemington, NJ 08822Andrey Espinoza, MD · Study contactMore trials in Flemington
- Virtua Health, Inc. · Marlton, NJ 08053Mark T. Finch, MD · Study contactMore trials in Marlton
- Rutgers State University · New Brunswick, NJ 08901Sabahat Bokhari, MD · Study contactMore trials in New Brunswick
- The Valley Hospital · Paramus, NJ 07652Himanshu Gupta, MD · Study contactMore trials in Paramus
- Holy Name Medical Center · Teaneck, NJ 07666Jaffar Raza, MD · Study contactMore trials in Teaneck
NV
- Southwest Medical Associates- Optum Nevada · Las Vegas, NV 89102Tatiana O. Tsvetkova, MD · Study contactMore trials in Las Vegas
- Vector Clinical Trials · Las Vegas, NV 89128Bharat R. Mocherla, MD · Study contactMore trials in Las Vegas
NY
- Clindove Research · Brooklyn, NY 11221Nelly Cohen, MD · Study contactMore trials in Brooklyn
- Swift Clinical Research · Brooklyn, NY 11226Manoj Dalmia, MD · Study contactMore trials in Brooklyn
- Rasaj Research · Jackson Heights, NY 11372Ammara Mushtaq, MD · Study contactMore trials in Jackson Heights
- Optum- Long Island NY · Lake Success, NY 11042Steven Goldberg, MD · Study contactMore trials in Lake Success
- Northwell Health Northern Westchester Hospital · Mount Kisco, NY 10549Margaret Andersen, MD · Study contactMore trials in Mount Kisco
- Mount Sinai West · New York, NY 10019Waqas A Malick, MD · Study contactMore trials in New York
- Mount Sinai · New York, NY 10029Solomon Bienstock, MD · Study contactMore trials in New York
OH
- Summa Health · Akron, OH 44304Wissam Alajaji, MD · Study contactMore trials in Akron
OK
- Hightower Clinical · Oklahoma City, OK 73007Faisal Latif, MD · Study contactMore trials in Oklahoma City
- Medical Research International, LLC · Oklahoma City, OK 73109Joseph Grillo, MD · Study contactMore trials in Oklahoma City
- Ascension St. John - Jane Phillips Medical Center · Tulsa, OK 74104Michael Megaly, MD · Study contactMore trials in Tulsa
PA
- Capital Area Research · Camp Hill, PA 17011Venkatesh Nadar, MD · Study contactMore trials in Camp Hill
SC
- Medical University of South Carolina · Charleston, SC 29425Marc-Andre Cornier, MD · Study contactMore trials in Charleston
TN
- Community DPC · Cleveland, TN 37312Carlton Volberg, MD · Study contactMore trials in Cleveland
- University of Tennessee Medical Center · Knoxville, TN 37920Kashif A. Shaikh, MD · Study contactMore trials in Knoxville
- TriStar Centennial Medical Center (HCA Health Care) · Nashville, TN 37202David Huneycutt, MD · Study contactMore trials in Nashville
TX
- Hendrick Health · Abilene, TX 79601Ren Zhang, MD · Study contactMore trials in Abilene
- Gadolin Research · Beaumont, TX 77702John T Fowler, MD · Study contactMore trials in Beaumont
- CardioVoyage, LLC · Greenville, TX 75402Marc Demyun, MD · Study contactMore trials in Greenville
- Helium Research Group · Houston, TX 77004Ijeoma A. Ekeruo · Study contactMore trials in Houston
- Kelsey Research Foundation · Houston, TX 77025Rohan R Wagle, MD · Study contactMore trials in Houston
- The Methodist Hospital, DeBakey Cardiology Associates · Houston, TX 77030Sadeer Al-Kindi, MD · Study contactMore trials in Houston
- Gulf Coast Clinical Research, LLC · Houston, TX 77070Anjani Pandya, MD · Study contactMore trials in Houston
- Aeres Clinical Research · Laredo, TX 78041Amando Garza, MD · Study contactMore trials in Laredo
- DC Clinical Research · Lewisville, TX 75057Moiz M. Shafiq, MD · Study contactMore trials in Lewisville
- North Dallas Research Associates - Kerlo Network · McKinney, TX 75069Muhammad Akram Khan, MD · Study contactMore trials in McKinney
- SMS Clinical Research · Mesquite, TX 75149Salma Saiger, MD · Study contactMore trials in Mesquite
- Privia Medical Group Gulf Coast, PLLC ( Javara Inc.) · San Marcos, TX 78666Alan Lee, MD · Study contactMore trials in San Marcos
- Privia Medical Group- North Texas · Stephenville, TX 76401Benjamin Marcum, MD · Study contactMore trials in Stephenville
UT
- Kalo Clinical Research · West Valley City, UT 84120William J. Walsh, MD · Study contactMore trials in West Valley City
VA
- Chippenham Johnston Willis Medical Center · Richmond, VA 23225Michael Arcarese, MD · Study contactMore trials in Richmond
WA
- Providence Regional Medical Center Everett · Everett, WA 98201Xiaojing Jennie Shen, MD · Study contactMore trials in Everett
- University of Washington · Seattle, WA 98195Kelley Branch, MD · Study contactMore trials in Seattle
WV
- Charleston Area Medical Center · Charleston, WV 25304Sarah Rinehart, MD · Study contactMore trials in Charleston