Recruiting

CAD Staging System

Sponsor:

Cleerly, Inc.

Code:

NCT06112418

Conditions

Diabetes Mellitus, Type 2

PreDiabetes

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

The Cleerly CAD Staging System

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

PreDiabetes

Metabolic Syndrome

Study ID

NCT06112418

Start date

Mar 6, 2024

Status verified date

Aug, 2026

Completion date

Mar 5, 2029

Anticipated

Primary completion date

Mar 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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

7500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Risk Factor-Based Care

The risk factor-based care group will be managed by their usual care providers, with an initial pre-randomization assessment of current treatment by a centralized cardiology team to optimize care relative to primary prevention guidelines. During the trial, the centralized cardiology team will monitor the provision of medications prescribed and lab values relative to guidelines, and provide feedback and education to site investigators to support optimization. CCTA results will be centrally archived and will remain blinded to the usual care provider until the end of the study.

experimental: Cleerly Stage-Based Care

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.

Interventions

The 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.

Primary outcome measure

  • The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events. [ Time Frame: Through study completion- an average of 3.5 years ]

Central Contacts and Locations

Central contacts

Ryann Sardinia

7207398191ryann.sardinia@cleerlyhealth.com

Ashley Dunham, PhD

7207398191ashley.dunham@cleerlyhealth.com

Locations

Chandler Clinical Trials

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Chandler, Arizona, United States, 85224

Scottsdale Clinical Trials

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Scottsdale, Arizona, United States, 85260

Sun City Research

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Sun City, Arizona, United States, 85381

Noble Clinical Research

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Tucson, Arizona, United States, 85704

Cardiovascular Research Foundation of Southern California

Recruiting

Beverly Hills, California, United States, 90210

Amicis Research: Beverly Hills

Recruiting

Beverly Hills, California, United States, 90211

Valiance Clinical Research - Canoga Park

Recruiting

Canoga Park, California, United States, 91303

Cardiovascular Institute of San Diego

Recruiting

Chula Vista, California, United States, 91911

Amicis Research: Granada Hills

Recruiting

Granada Hills, California, United States, 91324

Valiance Clinical Research: Huntington Park

Recruiting

Huntington Park, California, United States, 90255

HALO Diagnostics

Recruiting

Indian Wells, California, United States, 92210

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Chemidox Clinical Trials

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Lancaster, California, United States, 93534

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Long Beach Research Institute

Recruiting

Long Beach, California, United States, 90805

Ace Research Institute - Monterey Park

Recruiting

Monterey Park, California, United States, 91754

Amicis Research: Newhall

Recruiting

Newhall, California, United States, 91321

Ace Research Institute: Northridge

Recruiting

Northridge, California, United States, 91324

Amicis Research: Northridge

Recruiting

Northridge, California, United States, 91324

Ace Research Institute: Northridge #2

Recruiting

Northridge, California, United States, 91325

University of California- Irvine

Recruiting

Orange, California, United States, 92868

Stanford Health Care

Recruiting

Palo Alto, California, United States, 94304

VA Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Amicis Research: San Fernando

Recruiting

San Fernando, California, United States, 91306

Valiance Clinical Research - Tarzana

Recruiting

Tarzana, California, United States, 91356

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Amicis Research: Valencia

Recruiting

Valencia, California, United States, 91355

Concierge Clinical Trials

Recruiting

Valley Village, California, United States, 91607

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Steve Simon, MD

St. Josephs (Intermountain Healthcare)

Recruiting

Denver, Colorado, United States, 80218

Flourish Medical Research

Recruiting

Boca Raton, Florida, United States, 33434

Apex Research

Recruiting

Cross City, Florida, United States, 32628

Evolution Research Center

Recruiting

Hialeah, Florida, United States, 33012

UF Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Fiel Wellness Clinical Research LLC

Recruiting

Miami, Florida, United States, 33135

BioPhase Research

Recruiting

Miami, Florida, United States, 33137

United Clinical Research

Recruiting

Miami, Florida, United States, 33155

Atlantis Clinical Research, LLC

Recruiting

Miami, Florida, United States, 33173

Baptist Health Miami Cardiac and Vascular Institute

Recruiting

Miami, Florida, United States, 33173

Farma Medical Inc.

Recruiting

Miami, Florida, United States, 33183

New Access Research and Medical Center

Recruiting

Miami, Florida, United States, 33186

Quantum Clinical Trials

Recruiting

Miami Beach, Florida, United States, 33140

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Clinical Research Center of Florida

Recruiting

Pompano Beach, Florida, United States, 33060

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Aiyan Diabetes Center

Recruiting

Augusta, Georgia, United States, 30907

Emory University

Recruiting

Dunwoody, Georgia, United States, 30338

Privia Medical Group Georgia LLC -Fayetteville (Javara)

Recruiting

Fayetteville, Georgia, United States, 30214

Randomize Now- Atlanta West

Recruiting

Lithia Springs, Georgia, United States, 30122

Randomize Now-Burton Medical

Recruiting

Macon, Georgia, United States, 31210

Evergreen Clinical Trials

Recruiting

Norcross, Georgia, United States, 30092

Peachtree Clinical Solutions - Noir Research Collective

Recruiting

Powder Springs, Georgia, United States, 30127

Randomize Now, LLC - Noir Research Collective

Recruiting

Riverdale, Georgia, United States, 30296

Privia Medical Group Georgia, LLC (Javara Inc.)

Recruiting

Savannah, Georgia, United States, 31406

Privia Medical Group Georgia - Thomasville (Javara)

Recruiting

Thomasville, Georgia, United States, 31792

Care Institute- High Desert

Recruiting

Meridian, Idaho, United States, 83642

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Northshore University Health System

Recruiting

Glenview, Illinois, United States, 60026

Indiana Medical Research Institute

Recruiting

Indianapolis, Indiana, United States, 46202

Franciscan Physician Network- Indiana Heart Physicians

Recruiting

Indianapolis, Indiana, United States, 46237

MercyOne Iowa Heart Center

Recruiting

West Des Moines, Iowa, United States, 50266

St Elizabeth Health Care - CRI

Recruiting

Edgewood, Kentucky, United States, 41017

UofL Health

Recruiting

Louisville, Kentucky, United States, 40202

Ascension DePaul Services Research Center

Recruiting

New Orleans, Louisiana, United States, 70127

Flourish Bowie dba Flourish Research

Recruiting

Bowie, Maryland, United States, 20715

KUR Research at CMP

Recruiting

Columbia, Maryland, United States, 21045

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Trinity Health Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48917

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Saint Louis Heart and Vascular

Recruiting

St Louis, Missouri, United States, 63136

Boeson Research Kalispell

Recruiting

Kalispell, Montana, United States, 59901

Boeson Research Fort Missoula

Recruiting

Missoula, Montana, United States, 59804

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

Southwest Medical Associates- Optum Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Advanced Heart and Vascular Institute of Hunterdon

Recruiting

Flemington, New Jersey, United States, 08822

Virtua Health, Inc.

Recruiting

Marlton, New Jersey, United States, 08053

Rutgers State University

Recruiting

New Brunswick, New Jersey, United States, 08901

The Valley Hospital

Recruiting

Paramus, New Jersey, United States, 07652

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

Clindove Research

Recruiting

Brooklyn, New York, United States, 11221

Swift Clinical Research

Recruiting

Brooklyn, New York, United States, 11226

Rasaj Research

Recruiting

Jackson Heights, New York, United States, 11372

Optum- Long Island NY

Recruiting

Lake Success, New York, United States, 11042

Northwell Health Northern Westchester Hospital

Recruiting

Mount Kisco, New York, United States, 10549

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Mount Sinai

Recruiting

New York, New York, United States, 10029

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27701

Durham Veterans Affairs Medical Center (Durham VAMC)

Recruiting

Durham, North Carolina, United States, 27705

Cape Fear Valley Health System (Javara Inc.)

Recruiting

Fayetteville, North Carolina, United States, 28304

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Sanford Health

Recruiting

Fargo, North Dakota, United States, 58102

Summa Health

Recruiting

Akron, Ohio, United States, 44304

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73007

Medical Research International, LLC

Recruiting

Oklahoma City, Oklahoma, United States, 73109

Ascension St. John - Jane Phillips Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

Capital Area Research

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Community DPC

Recruiting

Cleveland, Tennessee, United States, 37312

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

TriStar Centennial Medical Center (HCA Health Care)

Recruiting

Nashville, Tennessee, United States, 37202

Hendrick Health

Recruiting

Abilene, Texas, United States, 79601

Gadolin Research

Recruiting

Beaumont, Texas, United States, 77702

CardioVoyage, LLC

Recruiting

Greenville, Texas, United States, 75402

Helium Research Group

Recruiting

Houston, Texas, United States, 77004

Kelsey Research Foundation

Recruiting

Houston, Texas, United States, 77025

The Methodist Hospital, DeBakey Cardiology Associates

Recruiting

Houston, Texas, United States, 77030

Gulf Coast Clinical Research, LLC

Recruiting

Houston, Texas, United States, 77070

Aeres Clinical Research

Recruiting

Laredo, Texas, United States, 78041

DC Clinical Research

Recruiting

Lewisville, Texas, United States, 75057

North Dallas Research Associates - Kerlo Network

Recruiting

McKinney, Texas, United States, 75069

SMS Clinical Research

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Mesquite, Texas, United States, 75149

Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)

Recruiting

San Marcos, Texas, United States, 78666

Privia Medical Group- North Texas

Recruiting

Stephenville, Texas, United States, 76401

Chippenham Johnston Willis Medical Center

Recruiting

Richmond, Virginia, United States, 23225

Providence Regional Medical Center Everett

Recruiting

Everett, Washington, United States, 98201

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Charleston Area Medical Center

Recruiting

Charleston, West Virginia, United States, 25304

More Information

Sponsor

Cleerly, Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cleerly, Inc. on 2026-08-19.