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

May 19, 2026 updated by: Cleerly, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) persists as the leading cause of morbidity and mortality worldwide at high societal cost. The current primary CVD prevention strategy relies upon risk stratification using population health markers such as age, sex, diabetes, hypertension, dyslipidemia and tobacco use, with preventive therapy intensified in higher risk strata. Since these risk factors are indirect surrogate markers of the underlying disease, atherosclerosis, this strategy leads to treatment of individuals with risk factors who do not have atherosclerosis and failure to treat those with significant atherosclerosis who lack risk factors. The current strategy also cannot determine which individuals are inadequately treated despite effective risk factor management (residual risk). With the current approach, the CV death rate is trending upward in the US despite evidence that screening asymptomatic patients reduces CV events and the widespread availability of effective preventive therapies.

This randomized, controlled, pragmatic trial is designed to address the unmet need for better strategies to identify asymptomatic individuals at increased risk for CV events due to atherosclerosis and to personalize their treatment based on CV risk estimates using coronary artery disease (CAD) visualization and quantification.

This study enrolls patients without known symptoms of ASCVD but who are at increased risk for ASCVD due to their age and having diabetes, prediabetes or metabolic syndrome and tests the hypothesis that a CAD Staging System-based care strategy reduces CV events compared with risk factor-based care. The Cleerly CAD Staging System incorporates imaging-based evaluation for coronary atherosclerosis, algorithm-supported pharmacotherapy and personalized education about their CAD.

Study Type

Interventional

Enrollment (Estimated)

7500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Chandler Clinical Trials
        • Contact:
          • Muhammad Salim, MD
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Scottsdale Clinical Trials
        • Contact:
          • Todd Dreitzler, MD
      • Sun City, Arizona, United States, 85381
        • Recruiting
        • Sun City Research
        • Contact:
          • Juan Rodriguez, MD
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Noble Clinical Research
        • Contact:
          • Roxana Rodriguez, MD
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Cardiovascular Research Foundation of Southern California
        • Contact:
          • Ronald P. Karlsberg, MD
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Amicis Research: Beverly Hills
        • Contact:
          • Michael Levine, MD
      • Canoga Park, California, United States, 91303
        • Recruiting
        • Valiance Clinical Research - Canoga Park
        • Contact:
          • Rami Shaarawy
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Cardiovascular Institute of San Diego
        • Contact:
          • Milind D. Parikh, MD
      • Granada Hills, California, United States, 91324
        • Recruiting
        • Amicis Research: Granada Hills
        • Contact:
          • Pascal Dabel, MD
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Valiance Clinical Research: Huntington Park
        • Contact:
          • Philip Kim, MD
      • Indian Wells, California, United States, 92210
        • Recruiting
        • HALO Diagnostics
        • Contact:
          • John F. Feller, MD
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Health
        • Contact:
          • Elizabeth Epstein, MD
      • Lancaster, California, United States, 93534
        • Recruiting
        • Chemidox Clinical Trials
        • Contact:
          • Pamela Dewar-DeSilva, MD
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health
        • Contact:
          • Purvi Parwani, MD
      • Long Beach, California, United States, 90805
        • Recruiting
        • Long Beach Research Institute
        • Contact:
          • Ashley Duzik, MD
      • Monterey Park, California, United States, 91754
        • Recruiting
        • Ace Research Institute - Monterey Park
        • Contact:
          • Yu-Hsiang Sam Lee, MD
      • Newhall, California, United States, 91321
        • Recruiting
        • Amicis Research: Newhall
        • Contact:
          • Thuong Vo, MD
      • Northridge, California, United States, 91325
        • Recruiting
        • Northridge Clinical Trials
        • Contact:
          • Sabreen S. Faqihi, MD
      • Northridge, California, United States, 91324
        • Recruiting
        • Ace Research Institute: Northridge
        • Contact:
          • Richard Park, MD
      • Northridge, California, United States, 91324
        • Recruiting
        • Amicis Research: Northridge
        • Contact:
          • Nana Barseghian, MD
      • Northridge, California, United States, 91325
        • Recruiting
        • Ace Research Institute: Northridge #2
        • Contact:
          • William Y. Josephson, MD
      • Orange, California, United States, 92868
        • Recruiting
        • University of California- Irvine
        • Contact:
          • Ailin Barseghian El-Farra, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Health Care
        • Contact:
          • Sandra Tsai, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto
        • Contact:
          • Shriram Nallamshetty, MD
      • San Fernando, California, United States, 91306
        • Recruiting
        • Amicis Research: San Fernando
        • Contact:
          • Farid Yasharpour, MD
      • Tarzana, California, United States, 91356
        • Recruiting
        • Valiance Clinical Research - Tarzana
        • Contact:
          • Harpreet Singh, MD
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
        • Contact:
          • Suvasini Lakshmanan, MD
      • Valencia, California, United States, 91355
        • Recruiting
        • Amicis Research: Valencia
        • Contact:
          • Dennis Lewis, MD
      • Valley Village, California, United States, 91607
        • Recruiting
        • Concierge Clinical Trials
        • Contact:
          • Ruth Espinoza, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Steve Simon
        • Principal Investigator:
          • Steve Simon, MD
      • Denver, Colorado, United States, 80218
        • Recruiting
        • St. Josephs (Intermountain Healthcare)
        • Contact:
          • Christopher Angus, MD
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Flourish Medical Research
        • Contact:
          • Michael Hafran, MD
      • Cross City, Florida, United States, 32628
        • Recruiting
        • Apex Research
        • Contact:
          • Tamir Salmani, MD
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Evolution Research Center
        • Contact:
          • Riquel Gonzalez, MD
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • UF Health Jacksonville
        • Contact:
          • Luis Ortega Paz, MD
      • Miami, Florida, United States, 33137
        • Recruiting
        • BioPhase Research
        • Contact:
          • Julie Cadet-Plassman, MD
      • Miami, Florida, United States, 33135
        • Recruiting
        • Fiel Wellness Clinical Research LLC
        • Contact:
          • Osvaldo Caroma, MD
      • Miami, Florida, United States, 33155
        • Recruiting
        • United Clinical Research
        • Contact:
          • Teresa B. Alfonso, MD
        • Contact:
          • Alfonso
      • Miami, Florida, United States, 33173
        • Recruiting
        • Atlantis Clinical Research, LLC
        • Contact:
          • Leyvi Alvarado Miranda, MD
      • Miami, Florida, United States, 33183
        • Recruiting
        • Farma Medical Inc.
        • Contact:
          • Ingrid Fernandez-Milian, MD
      • Miami, Florida, United States, 33173
        • Recruiting
        • Baptist Health Miami Cardiac and Vascular Institute
        • Contact:
          • Jonathan Fialkow, MD
      • Miami, Florida, United States, 33186
        • Recruiting
        • New Access Research and Medical Center
        • Contact:
          • Sander Fernandez, MD
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Quantum Clinical Trials
        • Contact:
          • Christopher A. Fayeghi, MD
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Ascension Sacred Heart
        • Contact:
          • Lauren J. Stipp, MD
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Research Center Of Florida
        • Contact:
          • Howard S. Koch, MD
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
        • Contact:
          • Shone Almeida, MD
    • Georgia
      • Augusta, Georgia, United States, 30907
        • Recruiting
        • Aiyan Diabetes Center
        • Contact:
          • Anthony D. Turner, MD
      • Dunwoody, Georgia, United States, 30338
        • Recruiting
        • Emory University
        • Contact:
          • Ambar Kulshreshtha, MD
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Privia Medical Group Georgia LLC -Fayetteville (Javara)
        • Contact:
          • Charlotte Grayson Mathis, MD
      • Lithia Springs, Georgia, United States, 30122
        • Recruiting
        • Randomize Now- Atlanta West
        • Contact:
          • Millard Collier Jr., MD
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Randomize Now-Burton Medical
        • Contact:
          • Frederick Burton, MD
      • Norcross, Georgia, United States, 30092
        • Recruiting
        • Evergreen Clinical Trials
        • Contact:
          • Dmitriy Pelishev, MD
      • Powder Springs, Georgia, United States, 30127
        • Recruiting
        • Peachtree Clinical Solutions - Noir Research Collective
        • Contact:
          • Karan Raghavan, MD
      • Riverdale, Georgia, United States, 30296
        • Recruiting
        • Randomize Now, LLC - Noir Research Collective
        • Contact:
          • Claire K. Willie, MD
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Privia Medical Group Georgia, LLC (Javara Inc.)
        • Contact:
          • Thomas G. Moriarity, MD
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Privia Medical Group Georgia - Thomasville (Javara)
        • Contact:
          • William L. Cooper, MD
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Care Institute- High Desert
        • Contact:
          • David A. Hinchman, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • Paul C. Cremer, MD
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University Health System
        • Contact:
          • Amit K. Pursnani, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Physician Network- Indiana Heart Physicians
        • Contact:
          • Ryan P Daly, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana Medical Research Institute
        • Contact:
          • Arshad P. Malik
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • MercyOne Iowa Heart Center
        • Contact:
          • Enrico L. Martin, MD
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St Elizabeth Health Care - CRI
        • Contact:
          • Erica Pivato, MD
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • UofL Health
        • Contact:
          • Shahab Ghafghazi, MD
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Bowie dba Flourish Research
        • Contact:
          • Sara Collins, MD
      • Columbia, Maryland, United States, 21045
        • Recruiting
        • KUR Research at CMP
        • Contact:
          • William Saway, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • Ron Blankstein, MD
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Pradeep Natarajan, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Cori E Russell, MD
      • Ypsilanti, Michigan, United States, 48917
        • Recruiting
        • Trinity Health Michigan Heart
        • Contact:
          • Ahmad Mizyed, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
          • Michael D. Miedema, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Farhan M. Katchi, MD
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Saint Louis Heart and Vascular
        • Contact:
          • Gil Vardi, MD
    • Montana
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Boeson Research Kalispell
        • Contact:
          • Justin Buls, MD
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research Fort Missoula
        • Contact:
          • Audrey Remmers, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Bryan Heart
        • Contact:
          • Chad E. Travers, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Vector Clinical Trials
        • Contact:
          • Bharat R. Mocherla, MD
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Southwest Medical Associates- Optum Nevada
        • Contact:
          • Tatiana O. Tsvetkova, MD
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Recruiting
        • Advanced Heart and Vascular Institute of Hunterdon
        • Contact:
          • Andrey Espinoza, MD
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health, Inc.
        • Contact:
          • Mark T. Finch, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers State University
        • Contact:
          • Sabahat Bokhari, MD
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • The Valley Hospital
        • Contact:
          • Himanshu Gupta, MD
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
        • Contact:
          • Jaffar Raza, MD
    • New York
      • Brooklyn, New York, United States, 11221
        • Recruiting
        • Clindove Research
        • Contact:
          • Nelly Cohen, MD
      • Brooklyn, New York, United States, 11226
        • Recruiting
        • Swift Clinical Research
        • Contact:
          • Manoj Dalmia, MD
      • Jackson Heights, New York, United States, 11372
        • Recruiting
        • Rasaj Research
        • Contact:
          • Ammara Mushtaq, MD
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Optum- Long Island NY
        • Contact:
          • Steven Goldberg, MD
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northwell Health Northern Westchester Hospital
        • Contact:
          • Margaret Andersen, MD
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
        • Contact:
          • Waqas A Malick, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
        • Contact:
          • Solomon Bienstock, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
          • Matthew Cavender, MD
      • Durham, North Carolina, United States, 27701
        • Recruiting
        • Duke University Hospital
        • Contact:
          • William Yancy, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham Veterans Affairs Medical Center (Durham VAMC)
        • Contact:
          • Hayden Bosworth, MD
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Cape Fear Valley Health System (Javara Inc.)
        • Contact:
          • Nafisa Saleem, MD
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • West Clinical Research
        • Contact:
          • Patrick J. Morgante, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Michael Shapiro, MD
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Health
        • Contact:
          • David J. Clardy, MD
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health
        • Contact:
          • Wissam Alajaji, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Recruiting
        • Medical Research International, LLC
        • Contact:
          • Joseph Grillo, MD
      • Oklahoma City, Oklahoma, United States, 73007
        • Recruiting
        • Hightower Clinical
        • Contact:
          • Faisal Latif, MD
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Ascension St. John - Jane Phillips Medical Center
        • Contact:
          • Michael Megaly, MD
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • Capital Area Research
        • Contact:
          • Venkatesh Nadar, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Marc-Andre Cornier, MD
    • Tennessee
      • Cleveland, Tennessee, United States, 37312
        • Recruiting
        • Community DPC
        • Contact:
          • Carlton Volberg, MD
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
        • Contact:
          • Kashif A. Shaikh, MD
      • Nashville, Tennessee, United States, 37202
        • Recruiting
        • TriStar Centennial Medical Center (HCA Health Care)
        • Contact:
          • David Huneycutt, MD
    • Texas
      • Abilene, Texas, United States, 79601
        • Recruiting
        • Hendrick Health
        • Contact:
          • Ren Zhang, MD
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Gadolin Research
        • Contact:
          • John T Fowler, MD
      • Greenville, Texas, United States, 75402
        • Recruiting
        • CardioVoyage, LLC
        • Contact:
          • Marc Demyun, MD
      • Houston, Texas, United States, 77025
        • Recruiting
        • Kelsey Research Foundation
        • Contact:
          • Rohan R Wagle, MD
      • Houston, Texas, United States, 77004
        • Recruiting
        • Helium Research Group
        • Contact:
          • Ijeoma A. Ekeruo
      • Houston, Texas, United States, 77070
        • Recruiting
        • Gulf Coast Clinical Research, LLC
        • Contact:
          • Anjani Pandya, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital, DeBakey Cardiology Associates
        • Contact:
          • Sadeer Al-Kindi, MD
      • Laredo, Texas, United States, 78041
        • Recruiting
        • Aeres Clinical Research
        • Contact:
          • Amando Garza, MD
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • DC Clinical Research
        • Contact:
          • Moiz M. Shafiq, MD
      • McKinney, Texas, United States, 75069
        • Recruiting
        • North Dallas Research Associates - Kerlo Network
        • Contact:
          • Muhammad Akram Khan, MD
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • SMS Clinical Research
        • Contact:
          • Salma Saiger, MD
      • San Marcos, Texas, United States, 78666
        • Recruiting
        • Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
        • Contact:
          • Alan Lee, MD
      • Stephenville, Texas, United States, 76401
        • Recruiting
        • Privia Medical Group- North Texas
        • Contact:
          • Benjamin Marcum, MD
    • Utah
      • West Valley City, Utah, United States, 84120
        • Not yet recruiting
        • Kalo Clinical Research
        • Contact:
          • William J. Walsh, MD
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • Chippenham Johnston Willis Medical Center
        • Contact:
          • Michael Arcarese, MD
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Medical Center Everett
        • Contact:
          • Xiaojing Jennie Shen, MD
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • Kelley Branch, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • Charleston Area Medical Center
        • Contact:
          • Sarah Rinehart, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Risk Factor-Based Care
The 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.
Experimental: Cleerly Stage-Based Care
The 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.
Device: The Cleerly CAD Staging System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.
Time Frame: Through study completion- an average of 3.5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion- an average of 3.5 years
The secondary endpoints are time from randomization to first occurence of an event in the primary efficacy endpoint.
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.
Time Frame: Through study completion- an average of 3.5 years
The secondary endpoints are total occurences after randomization of the primary efficacy endpoing, kidney failure, sustained estimated glomerular filtration rate (eGFR) decrease >40% from baseline, and death from renal causes.
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.
Time Frame: Through study completion- an average of 3.5 years
The secondary endpoints are first and total occurrences after randomization of coronary death, MI, and urgent coronary revascularization.
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.
Time Frame: Through study completion- an average of 3.5 years
The secondary endpoints are time from randomization to first occurrence of MI or ischemic stroke.
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.
Time Frame: Through study completion- an average of 3.5 years
The secondary endpoints are time from randomization to all-cause death.
Through study completion- an average of 3.5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety objective is to assess harm with the 2 prevention strategies
Time Frame: Through study completion- an average of 3.5 years
The safety endpoints are Adverse events (AE) leading to discontinuation of study-recommended medication (DAE), serious AE (SAE), adverse device effect (ADE).
Through study completion- an average of 3.5 years
The safety objective is to assess harm with the 2 prevention strategies
Time Frame: Through study completion- an average of 3.5 years
The safety endpoints are 20-item Short Form survey (SF-20).
Through study completion- an average of 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleerly, Inc.

Collaborators

CPC Clinical Research

Investigators

  • Study Chair: Deepak Bhatt, MD, MPH, Mt. Sinai Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

March 5, 2029

Study Completion (Estimated)

March 5, 2029

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202302CPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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