RecruitingNot ApplicableNCT06112418

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

A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events


Sponsor

Cleerly, Inc.

Enrollment

7,500 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special heart CT scan (called a coronary CT angiography) to detect hidden plaque buildup in the arteries — then comparing whether personalized heart risk management or standard care does a better job at preventing heart attacks and strokes. You may be eligible if: - You are a man over 55 or a woman over 65 - You have type 2 diabetes requiring medication, pre-diabetes, or metabolic syndrome (a cluster of risk factors like high blood sugar, high blood pressure, excess waist size, and abnormal cholesterol) - You have a smartphone, tablet, or computer to communicate with the study team You may NOT be eligible if: - You have already had a heart attack, chest pain, stroke, leg artery disease, or a heart procedure - You are planning to have an artery procedure soon - You have significant kidney problems (eGFR below 60) - You have an allergy to iodine-based contrast dye used in CT scans - You have thyroid cancer or a planned radioactive iodine treatment - You weigh more than 300 lbs (136 kg) - You cannot hold your breath for 10 seconds (needed for the scan) - You have an irregular or fast heartbeat that is hard to control - You have a life expectancy of less than 3 years for any reason - You have significant blockage in the main heart artery detected by the scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEThe 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.


Locations(123)

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

Scripps Health

La Jolla, 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

University of California- Irvine

Orange, 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

Concierge Clinical Trials

Valley Village, 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

Privia Medical Group Georgia LLC -Fayetteville (Javara)

Fayetteville, Georgia, United States

Randomize Now- Atlanta West

Lithia Springs, Georgia, United States

Randomize Now-Burton Medical

Macon, Georgia, United States

Evergreen Clinical Trials

Norcross, 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

Privia Medical Group Georgia - Thomasville (Javara)

Thomasville, Georgia, United States

Care Institute- High Desert

Meridian, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Northshore University Health System

Glenview, 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

KUR Research at CMP

Columbia, 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

Durham Veterans Affairs Medical Center (Durham VAMC)

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

Kalo Clinical Research

West Valley City, Utah, United States

Chippenham Johnston Willis Medical Center

Richmond, Virginia, United States

Providence Regional Medical Center Everett

Everett, Washington, United States

University of Washington

Seattle, Washington, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06112418


Related Trials