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NCT06112418NARecruitingAccepts Healthy Volunteers

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

Cleerly, Inc.

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

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)

Interventions

DEVICE

The Cleerly CAD Staging System

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Conditions

Diabetes Mellitus, Type 2PreDiabetesMetabolic Syndrome

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