A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
- Conditions
- Diabetes Mellitus, Type 2Metabolic SyndromePreDiabetes
- Interventions
- Device: The Cleerly CAD Staging System
- Registration Number
- NCT06112418
- Lead Sponsor
- Cleerly, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7500
-
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
-
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cleerly Stage-Based Care The Cleerly CAD Staging System 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.
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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 endpoints are time from randomization to all-cause death.
Trial Locations
- Locations (82)
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
Long Beach Research Institute
🇺🇸Long Beach, 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
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
Quantum Clinical Trials
🇺🇸Miami Beach, 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
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Aiyan Diabetes Center
🇺🇸Augusta, Georgia, United States
Peachtree Clinical Solutions - Noir Research Collective
🇺🇸Powder Springs, 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
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint 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
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
Northwell Health Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
West Clinical Research
🇺🇸Morehead City, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Summa Health
🇺🇸Akron, Ohio, 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
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
Helium Research Group
🇺🇸Houston, Texas, United States
Kelsey Research Foundation
🇺🇸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
Chippenham Johnston Willis Medical Center
🇺🇸Richmond, Virginia, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States