A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
NCT ID: NCT06112418
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
7500 participants
INTERVENTIONAL
2024-03-06
2029-03-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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)
55 Years
ALL
Yes
Sponsors
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CPC Clinical Research
UNKNOWN
Cleerly, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deepak Bhatt, MD, MPH
Role: STUDY_CHAIR
Mt. Sinai Heart
Locations
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Chandler Clinical Trials
Chandler, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Sun City Research
Sun City, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
Amicis Research: Beverly Hills
Beverly Hills, California, United States
Valiance Clinical Research - Canoga Park
Canoga Park, California, United States
Cardiovascular Institute of San Diego
Chula Vista, California, United States
Amicis Research: Granada Hills
Granada Hills, California, United States
Valiance Clinical Research: Huntington Park
Huntington Park, California, United States
HALO Diagnostics
Indian Wells, California, United States
Chemidox Clinical Trials
Lancaster, California, United States
Long Beach Research Institute
Long Beach, California, United States
Ace Research Institute - Monterey Park
Monterey Park, California, United States
Amicis Research: Newhall
Newhall, California, United States
Ace Research Institute: Northridge
Northridge, California, United States
Amicis Research: Northridge
Northridge, California, United States
Ace Research Institute: Northridge #2
Northridge, California, United States
Northridge Clinical Trials
Northridge, California, United States
Stanford Health Care
Palo Alto, California, United States
VA Palo Alto
Palo Alto, California, United States
Amicis Research: San Fernando
San Fernando, California, United States
Valiance Clinical Research - Tarzana
Tarzana, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
Amicis Research: Valencia
Valencia, California, United States
University of Colorado
Aurora, Colorado, United States
St. Josephs (Intermountain Healthcare)
Denver, Colorado, United States
Flourish Medical Research
Boca Raton, Florida, United States
Apex Research
Cross City, Florida, United States
Evolution Research Center
Hialeah, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Fiel Wellness Clinical Research LLC
Miami, Florida, United States
BioPhase Research
Miami, Florida, United States
United Clinical Research
Miami, Florida, United States
Atlantis Clinical Research, LLC
Miami, Florida, United States
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, United States
Farma Medical Inc.
Miami, Florida, United States
New Access Research and Medical Center
Miami, Florida, United States
Quantum Clinical Trials
Miami Beach, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
University of South Florida
Tampa, Florida, United States
Aiyan Diabetes Center
Augusta, Georgia, United States
Emory University
Dunwoody, Georgia, United States
Peachtree Clinical Solutions - Noir Research Collective
Powder Springs, Georgia, United States
Randomize Now, LLC - Noir Research Collective
Riverdale, Georgia, United States
Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah, Georgia, United States
Care Institute- High Desert
Meridian, Idaho, United States
Northshore University Health System
Evanston, Illinois, United States
Indiana Medical Research Institute
Indianapolis, Indiana, United States
Franciscan Physician Network- Indiana Heart Physicians
Indianapolis, Indiana, United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, United States
St Elizabeth Health Care - CRI
Edgewood, Kentucky, United States
UofL Health
Louisville, Kentucky, United States
Flourish Bowie dba Flourish Research
Bowie, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Saint Louis Heart and Vascular
St Louis, Missouri, United States
Boeson Research Kalispell
Kalispell, Montana, United States
Boeson Research Fort Missoula
Missoula, Montana, United States
Bryan Heart
Lincoln, Nebraska, United States
Southwest Medical Associates- Optum Nevada
Las Vegas, Nevada, United States
Vector Clinical Trials
Las Vegas, Nevada, United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, United States
Virtua Health, Inc.
Marlton, New Jersey, United States
Rutgers State University
New Brunswick, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Clindove Research
Brooklyn, New York, United States
Swift Clinical Research
Brooklyn, New York, United States
Rasaj Research
Jackson Heights, New York, United States
Optum- Long Island NY
Lake Success, New York, United States
Northwell Health Northern Westchester Hospital
Mount Kisco, New York, United States
Mount Sinai West
New York, New York, United States
Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Cape Fear Valley Health System (Javara Inc.)
Fayetteville, North Carolina, United States
West Clinical Research
Morehead City, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Health
Fargo, North Dakota, United States
Summa Health
Akron, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Medical Research International, LLC
Oklahoma City, Oklahoma, United States
Ascension St. John - Jane Phillips Medical Center
Tulsa, Oklahoma, United States
Capital Area Research
Camp Hill, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Community DPC
Cleveland, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
TriStar Centennial Medical Center (HCA Health Care)
Nashville, Tennessee, United States
Hendrick Health
Abilene, Texas, United States
Gadolin Research
Beaumont, Texas, United States
CardioVoyage, LLC
Greenville, Texas, United States
Helium Research Group
Houston, Texas, United States
Kelsey Research Foundation
Houston, Texas, United States
The Methodist Hospital, DeBakey Cardiology Associates
Houston, Texas, United States
Gulf Coast Clinical Research, LLC
Houston, Texas, United States
Aeres Clinical Research
Laredo, Texas, United States
DC Clinical Research
Lewisville, Texas, United States
North Dallas Research Associates - Kerlo Network
McKinney, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
San Marcos, Texas, United States
Privia Medical Group- North Texas
Stephenville, Texas, United States
Chippenham Johnston Willis Medical Center
Richmond, Virginia, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Muhammad Salim, MD
Role: primary
Todd Dreitzler, MD
Role: primary
Juan Rodriguez, MD
Role: primary
Dena Petersen, MD
Role: primary
Ronald P. Karlsberg, MD
Role: primary
Michael Levine, MD
Role: primary
Rami Shaarawy
Role: primary
Milind D. Parikh, MD
Role: primary
Pascal Dabel, MD
Role: primary
Philip Kim, MD
Role: primary
John F. Feller, MD
Role: primary
Pamela Dewar-DeSilva, MD
Role: primary
Ashley Duzik, MD
Role: primary
Yu-Hsiang Sam Lee, MD
Role: primary
Thuong Vo, MD
Role: primary
Richard Park, MD
Role: primary
Nana Barseghian, MD
Role: primary
William Y. Josephson, MD
Role: primary
Sabreen S. Faqihi, MD
Role: primary
Sandra Tsai, MD
Role: primary
Shriram Nallamshetty, MD
Role: primary
Farid Yasharpour, MD
Role: primary
Harpreet Singh, MD
Role: primary
Suvasini Lakshmanan, MD
Role: primary
Dennis Lewis, MD
Role: primary
Steve Simon
Role: primary
Christopher Angus, MD
Role: primary
David Funt, MD
Role: primary
Tamir Salmani, MD
Role: primary
Riquel Gonzalez, MD
Role: primary
Luis Ortega Paz, MD
Role: primary
Osvaldo Caroma, MD
Role: primary
Julie Cadet-Plassman, MD
Role: primary
Teresa B. Alfonso, MD
Role: primary
Alfonso
Role: backup
Leyvi Alvarado Miranda, MD
Role: primary
Jonathan Fialkow, MD
Role: primary
Alba Obourke, MD
Role: primary
Sander Fernandez, MD
Role: primary
Christopher A. Fayeghi, MD
Role: primary
Lauren J. Stipp, MD
Role: primary
Howard S. Koch, MD
Role: primary
Shone Almeida, MD
Role: primary
Alain Domkam, MD
Role: primary
Ambar Kulshreshtha, MD
Role: primary
Karan Raghavan, MD
Role: primary
Claire K. Willie, MD
Role: primary
Thomas G. Moriarity, MD
Role: primary
David A. Hinchman, MD
Role: primary
Amit K. Pursnani, MD
Role: primary
Arshad P. Malik
Role: primary
Ryan P Daly, MD
Role: primary
Enrico L. Martin, MD
Role: primary
Erica Pivato, MD
Role: primary
Shahab Ghafghazi, MD
Role: primary
Sara Collins, MD
Role: primary
Pradeep Natarajan, MD
Role: primary
Ron Blankstein, MD
Role: primary
Cori E Russell, MD
Role: primary
Ahmad Mizyed, MD
Role: primary
Michael D. Miedema, MD
Role: primary
Farhan M. Katchi, MD
Role: primary
Gil Vardi, MD
Role: primary
Justin Buls, MD
Role: primary
Audrey Remmers, MD
Role: primary
Natraj Katta, MD
Role: primary
Tatiana O. Tsvetkova, MD
Role: primary
Bharat R. Mocherla, MD
Role: primary
Andrey Espinoza, MD
Role: primary
Mark T. Finch, MD
Role: primary
Sabahat Bokhari, MD
Role: primary
Himanshu Gupta, MD
Role: primary
Jaffar Raza, MD
Role: primary
Nelly Cohen, MD
Role: primary
Manoj Dalmia, MD
Role: primary
Ammara Mushtaq, MD
Role: primary
Steven Goldberg, MD
Role: primary
Margaret Andersen, MD
Role: primary
Waqas A Malick, MD
Role: primary
Solomon Bienstock, MD
Role: primary
Matthew Cavender, MD
Role: primary
William Yancy, MD
Role: primary
Nafisa Saleem, MD
Role: primary
Patrick J. Morgante, MD
Role: primary
Michael Shapiro, MD
Role: primary
David J. Clardy, MD
Role: primary
Wissam Alajaji, MD
Role: primary
Faisal Latif, MD
Role: primary
Joseph Grillo, MD
Role: primary
Michael Megaly, MD
Role: primary
Venkatesh Nadar, MD
Role: primary
Marc-Andre Cornier, MD
Role: primary
Carlton Volberg, MD
Role: primary
Kashif A. Shaikh, MD
Role: primary
David Huneycutt, MD
Role: primary
Ren Zhang, MD
Role: primary
John T Fowler, MD
Role: primary
Marc Demyun, MD
Role: primary
Ijeoma A. Ekeruo
Role: primary
Rohan R Wagle, MD
Role: primary
Sadeer Al-Kindi, MD
Role: primary
Anjani Pandya, MD
Role: primary
Amando Garza, MD
Role: primary
Moiz M. Shafiq, MD
Role: primary
Muhammad Akram Khan, MD
Role: primary
Salma Saiger, MD
Role: primary
Alan Lee, MD
Role: primary
Benjamin Marcum, MD
Role: primary
Michael Arcarese, MD
Role: primary
Sarah Rinehart, MD
Role: primary
References
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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.
Clerc 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.
Related Links
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World Health Organization - Cardiovascular Diseases
Other Identifiers
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202302CPC
Identifier Type: -
Identifier Source: org_study_id