TrialPath
← Back to searchRecruiting

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

NCT06112418 · Cleerly, Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events
About this study
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.
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 design
Enrollment target: 7500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-06
Estimated completion: 2029-03-05
Last updated: 2026-04-14
Interventions
Device: The Cleerly CAD Staging System
Primary outcomes
  • The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events. (Through study completion- an average of 3.5 years)
Sponsor
Cleerly, Inc. · industry
With: CPC Clinical Research
Contacts & investigators
ContactRyann Sardinia · contact · ryann.sardinia@cleerlyhealth.com · 7207398191
ContactAshley Dunham, PhD · contact · ashley.dunham@cleerlyhealth.com · 7207398191
InvestigatorDeepak Bhatt, MD, MPH · study_chair, Mt. Sinai Heart
All locations (123)
Chandler Clinical TrialsRecruiting
Chandler, Arizona, United States
Scottsdale Clinical TrialsRecruiting
Scottsdale, Arizona, United States
Sun City ResearchRecruiting
Sun City, Arizona, United States
Noble Clinical ResearchRecruiting
Tucson, Arizona, United States
Cardiovascular Research Foundation of Southern CaliforniaRecruiting
Beverly Hills, California, United States
Amicis Research: Beverly HillsRecruiting
Beverly Hills, California, United States
Valiance Clinical Research - Canoga ParkRecruiting
Canoga Park, California, United States
Cardiovascular Institute of San DiegoRecruiting
Chula Vista, California, United States
Amicis Research: Granada HillsRecruiting
Granada Hills, California, United States
Valiance Clinical Research: Huntington ParkRecruiting
Huntington Park, California, United States
HALO DiagnosticsRecruiting
Indian Wells, California, United States
Scripps HealthRecruiting
La Jolla, California, United States
Chemidox Clinical TrialsRecruiting
Lancaster, California, United States
Long Beach Research InstituteRecruiting
Long Beach, California, United States
Ace Research Institute - Monterey ParkRecruiting
Monterey Park, California, United States
Amicis Research: NewhallRecruiting
Newhall, California, United States
Ace Research Institute: NorthridgeRecruiting
Northridge, California, United States
Amicis Research: NorthridgeRecruiting
Northridge, California, United States
Ace Research Institute: Northridge #2Recruiting
Northridge, California, United States
Northridge Clinical TrialsRecruiting
Northridge, California, United States
University of California- IrvineRecruiting
Orange, California, United States
Stanford Health CareRecruiting
Palo Alto, California, United States
VA Palo AltoRecruiting
Palo Alto, California, United States
Amicis Research: San FernandoRecruiting
San Fernando, California, United States
Valiance Clinical Research - TarzanaRecruiting
Tarzana, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical CenterRecruiting
Torrance, California, United States
Amicis Research: ValenciaRecruiting
Valencia, California, United States
Concierge Clinical TrialsRecruiting
Valley Village, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
St. Josephs (Intermountain Healthcare)Recruiting
Denver, Colorado, United States
Flourish Medical ResearchRecruiting
Boca Raton, Florida, United States
Apex ResearchRecruiting
Cross City, Florida, United States
Evolution Research CenterRecruiting
Hialeah, Florida, United States
UF Health JacksonvilleRecruiting
Jacksonville, Florida, United States
Fiel Wellness Clinical Research LLCRecruiting
Miami, Florida, United States
BioPhase ResearchRecruiting
Miami, Florida, United States
United Clinical ResearchRecruiting
Miami, Florida, United States
Atlantis Clinical Research, LLCRecruiting
Miami, Florida, United States
Baptist Health Miami Cardiac and Vascular InstituteRecruiting
Miami, Florida, United States
Farma Medical Inc.Recruiting
Miami, Florida, United States
New Access Research and Medical CenterRecruiting
Miami, Florida, United States
Quantum Clinical TrialsRecruiting
Miami Beach, Florida, United States
Ascension Sacred HeartRecruiting
Pensacola, Florida, United States
Clinical Research Center of FloridaRecruiting
Pompano Beach, Florida, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Aiyan Diabetes CenterRecruiting
Augusta, Georgia, United States
Emory UniversityRecruiting
Dunwoody, Georgia, United States
Privia Medical Group Georgia LLC -Fayetteville (Javara)Recruiting
Fayetteville, Georgia, United States
Randomize Now- Atlanta WestRecruiting
Lithia Springs, Georgia, United States
Randomize Now-Burton MedicalRecruiting
Macon, Georgia, United States
Evergreen Clinical TrialsRecruiting
Norcross, Georgia, United States
Peachtree Clinical Solutions - Noir Research CollectiveRecruiting
Powder Springs, Georgia, United States
Randomize Now, LLC - Noir Research CollectiveRecruiting
Riverdale, Georgia, United States
Privia Medical Group Georgia, LLC (Javara Inc.)Recruiting
Savannah, Georgia, United States
Privia Medical Group Georgia - Thomasville (Javara)Recruiting
Thomasville, Georgia, United States
Care Institute- High DesertRecruiting
Meridian, Idaho, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Northshore University Health SystemRecruiting
Glenview, Illinois, United States
Indiana Medical Research InstituteRecruiting
Indianapolis, Indiana, United States
Franciscan Physician Network- Indiana Heart PhysiciansRecruiting
Indianapolis, Indiana, United States
MercyOne Iowa Heart CenterRecruiting
West Des Moines, Iowa, United States
St Elizabeth Health Care - CRIRecruiting
Edgewood, Kentucky, United States
UofL HealthRecruiting
Louisville, Kentucky, United States
Flourish Bowie dba Flourish ResearchRecruiting
Bowie, Maryland, United States
KUR Research at CMPRecruiting
Columbia, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Trinity Health Michigan HeartRecruiting
Ypsilanti, Michigan, United States
Minneapolis Heart Institute FoundationRecruiting
Minneapolis, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Saint Louis Heart and VascularRecruiting
St Louis, Missouri, United States
Boeson Research KalispellRecruiting
Kalispell, Montana, United States
Boeson Research Fort MissoulaRecruiting
Missoula, Montana, United States
Bryan HeartRecruiting
Lincoln, Nebraska, United States
Southwest Medical Associates- Optum NevadaRecruiting
Las Vegas, Nevada, United States
Vector Clinical TrialsRecruiting
Las Vegas, Nevada, United States
Advanced Heart and Vascular Institute of HunterdonRecruiting
Flemington, New Jersey, United States
Virtua Health, Inc.Recruiting
Marlton, New Jersey, United States
Rutgers State UniversityRecruiting
New Brunswick, New Jersey, United States
The Valley HospitalRecruiting
Paramus, New Jersey, United States
Holy Name Medical CenterRecruiting
Teaneck, New Jersey, United States
Clindove ResearchRecruiting
Brooklyn, New York, United States
Swift Clinical ResearchRecruiting
Brooklyn, New York, United States
Rasaj ResearchRecruiting
Jackson Heights, New York, United States
Optum- Long Island NYRecruiting
Lake Success, New York, United States
Northwell Health Northern Westchester HospitalRecruiting
Mount Kisco, New York, United States
Mount Sinai WestRecruiting
New York, New York, United States
Mount SinaiRecruiting
New York, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Duke University HospitalRecruiting
Durham, North Carolina, United States
Durham Veterans Affairs Medical Center (Durham VAMC)Recruiting
Durham, North Carolina, United States
Cape Fear Valley Health System (Javara Inc.)Recruiting
Fayetteville, North Carolina, United States
West Clinical ResearchRecruiting
Morehead City, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
Sanford HealthRecruiting
Fargo, North Dakota, United States
Summa HealthRecruiting
Akron, Ohio, United States
Hightower ClinicalRecruiting
Oklahoma City, Oklahoma, United States
Medical Research International, LLCRecruiting
Oklahoma City, Oklahoma, United States
Ascension St. John - Jane Phillips Medical CenterRecruiting
Tulsa, Oklahoma, United States
Capital Area ResearchRecruiting
Camp Hill, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Community DPCRecruiting
Cleveland, Tennessee, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
TriStar Centennial Medical Center (HCA Health Care)Recruiting
Nashville, Tennessee, United States
Hendrick HealthRecruiting
Abilene, Texas, United States
Gadolin ResearchRecruiting
Beaumont, Texas, United States
CardioVoyage, LLCRecruiting
Greenville, Texas, United States
Helium Research GroupRecruiting
Houston, Texas, United States
Kelsey Research FoundationRecruiting
Houston, Texas, United States
The Methodist Hospital, DeBakey Cardiology AssociatesRecruiting
Houston, Texas, United States
Gulf Coast Clinical Research, LLCRecruiting
Houston, Texas, United States
Aeres Clinical ResearchRecruiting
Laredo, Texas, United States
DC Clinical ResearchRecruiting
Lewisville, Texas, United States
North Dallas Research Associates - Kerlo NetworkRecruiting
McKinney, Texas, United States
SMS Clinical ResearchRecruiting
Mesquite, Texas, United States
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)Recruiting
San Marcos, Texas, United States
Privia Medical Group- North TexasRecruiting
Stephenville, Texas, United States
Kalo Clinical ResearchNot Yet Recruiting
West Valley City, Utah, United States
Chippenham Johnston Willis Medical CenterRecruiting
Richmond, Virginia, United States
Providence Regional Medical Center EverettRecruiting
Everett, Washington, United States
University of WashingtonRecruiting
Seattle, Washington, United States
Charleston Area Medical CenterRecruiting
Charleston, West Virginia, United States