A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
Start Date
3/6/2024
Completion Date
3/5/2029
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.
Eligibility Criteria
Age Range: 55 years to No maximum
Interventions
The Cleerly CAD Staging System
Conditions
Locations
Chandler Clinical Trials
Chandler, Arizona 85224
United States
Scottsdale Clinical Trials
Scottsdale, Arizona 85260
United States
Sun City Research
Sun City, Arizona 85381
United States
Noble Clinical Research
Tucson, Arizona 85704
United States
Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210
United States
Amicis Research: Beverly Hills
Beverly Hills, California 90211
United States
Valiance Clinical Research - Canoga Park
Canoga Park, California 91303
United States
Cardiovascular Institute of San Diego
Chula Vista, California 91911
United States
Amicis Research: Granada Hills
Granada Hills, California 91324
United States
Valiance Clinical Research: Huntington Park
Huntington Park, California 90255
United States
HALO Diagnostics
Indian Wells, California 92210
United States
Scripps Health
La Jolla, California 92037
United States
Chemidox Clinical Trials
Lancaster, California 93534
United States
Loma Linda University Health
Loma Linda, California 92354
United States
Long Beach Research Institute
Long Beach, California 90805
United States
Ace Research Institute - Monterey Park
Monterey Park, California 91754
United States
Amicis Research: Newhall
Newhall, California 91321
United States
Ace Research Institute: Northridge
Northridge, California 91324
United States
Amicis Research: Northridge
Northridge, California 91324
United States
Ace Research Institute: Northridge #2
Northridge, California 91325
United States
Northridge Clinical Trials
Northridge, California 91325
United States
University of California- Irvine
Orange, California 92868
United States
Stanford Health Care
Palo Alto, California 94304
United States
VA Palo Alto
Palo Alto, California 94304
United States
Amicis Research: San Fernando
San Fernando, California 91306
United States
Valiance Clinical Research - Tarzana
Tarzana, California 91356
United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California 90502
United States
Amicis Research: Valencia
Valencia, California 91355
United States
Concierge Clinical Trials
Valley Village, California 91607
United States
University of Colorado
Aurora, Colorado 80045
United States
St. Josephs (Intermountain Healthcare)
Denver, Colorado 80218
United States
Flourish Medical Research
Boca Raton, Florida 33434
United States
Apex Research
Cross City, Florida 32628
United States
Evolution Research Center
Hialeah, Florida 33012
United States
UF Health Jacksonville
Jacksonville, Florida 32209
United States
Fiel Wellness Clinical Research LLC
Miami, Florida 33135
United States
BioPhase Research
Miami, Florida 33137
United States
United Clinical Research
Miami, Florida 33155
United States
Atlantis Clinical Research, LLC
Miami, Florida 33173
United States
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida 33173
United States
Farma Medical Inc.
Miami, Florida 33183
United States
New Access Research and Medical Center
Miami, Florida 33186
United States
Quantum Clinical Trials
Miami Beach, Florida 33140
United States
Ascension Sacred Heart
Pensacola, Florida 32504
United States
Clinical Research Center of Florida
Pompano Beach, Florida 33060
United States
University of South Florida
Tampa, Florida 33620
United States
Aiyan Diabetes Center
Augusta, Georgia 30907
United States
Emory University
Dunwoody, Georgia 30338
United States
Privia Medical Group Georgia LLC -Fayetteville (Javara)
Fayetteville, Georgia 30214
United States
Randomize Now- Atlanta West
Lithia Springs, Georgia 30122
United States
Randomize Now-Burton Medical
Macon, Georgia 31210
United States
Evergreen Clinical Trials
Norcross, Georgia 30092
United States
Peachtree Clinical Solutions - Noir Research Collective
Powder Springs, Georgia 30127
United States
Randomize Now, LLC - Noir Research Collective
Riverdale, Georgia 30296
United States
Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah, Georgia 31406
United States
Privia Medical Group Georgia - Thomasville (Javara)
Thomasville, Georgia 31792
United States
Care Institute- High Desert
Meridian, Idaho 83642
United States
Northwestern University
Chicago, Illinois 60611
United States
Northshore University Health System
Glenview, Illinois 60026
United States
Indiana Medical Research Institute
Indianapolis, Indiana 46202
United States
Franciscan Physician Network- Indiana Heart Physicians
Indianapolis, Indiana 46237
United States
MercyOne Iowa Heart Center
West Des Moines, Iowa 50266
United States
St Elizabeth Health Care - CRI
Edgewood, Kentucky 41017
United States
UofL Health
Louisville, Kentucky 40202
United States
Ascension DePaul Services Research Center
New Orleans, Louisiana 70127
United States
Flourish Bowie dba Flourish Research
Bowie, Maryland 20715
United States
KUR Research at CMP
Columbia, Maryland 21045
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Trinity Health Michigan Heart
Ypsilanti, Michigan 48917
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Saint Louis Heart and Vascular
St Louis, Missouri 63136
United States
Boeson Research Kalispell
Kalispell, Montana 59901
United States
Boeson Research Fort Missoula
Missoula, Montana 59804
United States
Bryan Heart
Lincoln, Nebraska 68506
United States
Southwest Medical Associates- Optum Nevada
Las Vegas, Nevada 89102
United States
Vector Clinical Trials
Las Vegas, Nevada 89128
United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey 08822
United States
Virtua Health, Inc.
Marlton, New Jersey 08053
United States
Rutgers State University
New Brunswick, New Jersey 08901
United States
The Valley Hospital
Paramus, New Jersey 07652
United States
Holy Name Medical Center
Teaneck, New Jersey 07666
United States
Clindove Research
Brooklyn, New York 11221
United States
Swift Clinical Research
Brooklyn, New York 11226
United States
Rasaj Research
Jackson Heights, New York 11372
United States
Optum- Long Island NY
Lake Success, New York 11042
United States
Northwell Health Northern Westchester Hospital
Mount Kisco, New York 10549
United States
Mount Sinai West
New York, New York 10019
United States
Mount Sinai
New York, New York 10029
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Duke University Hospital
Durham, North Carolina 27701
United States
Durham Veterans Affairs Medical Center (Durham VAMC)
Durham, North Carolina 27705
United States
Cape Fear Valley Health System (Javara Inc.)
Fayetteville, North Carolina 28304
United States
West Clinical Research
Morehead City, North Carolina 28557
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Sanford Health
Fargo, North Dakota 58102
United States
Summa Health
Akron, Ohio 44304
United States
Hightower Clinical
Oklahoma City, Oklahoma 73007
United States
Medical Research International, LLC
Oklahoma City, Oklahoma 73109
United States
Ascension St. John - Jane Phillips Medical Center
Tulsa, Oklahoma 74104
United States
Capital Area Research
Camp Hill, Pennsylvania 17011
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Community DPC
Cleveland, Tennessee 37312
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
TriStar Centennial Medical Center (HCA Health Care)
Nashville, Tennessee 37202
United States
Hendrick Health
Abilene, Texas 79601
United States
Gadolin Research
Beaumont, Texas 77702
United States
CardioVoyage, LLC
Greenville, Texas 75402
United States
Helium Research Group
Houston, Texas 77004
United States
Kelsey Research Foundation
Houston, Texas 77025
United States
The Methodist Hospital, DeBakey Cardiology Associates
Houston, Texas 77030
United States
Gulf Coast Clinical Research, LLC
Houston, Texas 77070
United States
Aeres Clinical Research
Laredo, Texas 78041
United States
DC Clinical Research
Lewisville, Texas 75057
United States
North Dallas Research Associates - Kerlo Network
McKinney, Texas 75069
United States
SMS Clinical Research
Mesquite, Texas 75149
United States
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
San Marcos, Texas 78666
United States
Privia Medical Group- North Texas
Stephenville, Texas 76401
United States
Kalo Clinical Research
West Valley City, Utah 84120
United States
Chippenham Johnston Willis Medical Center
Richmond, Virginia 23225
United States
Providence Regional Medical Center Everett
Everett, Washington 98201
United States
University of Washington
Seattle, Washington 98195
United States
Charleston Area Medical Center
Charleston, West Virginia 25304
United States