Heart scan software aims to outsmart traditional risk calculators

NCT ID NCT06112418

Prevention Sponsor: Cleerly, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study is testing whether a special software that analyzes CT scans of the heart's arteries can better prevent heart attacks, strokes, and other cardiovascular events compared to usual care based on risk factors like cholesterol and blood pressure. The trial will enroll 7,500 adults over 55 (men) or 65 (women) with type 2 diabetes, prediabetes, or metabolic syndrome who have no known heart disease. Participants will be randomly assigned to have their treatment guided by the Cleerly CAD Staging System or by standard risk factor management, and researchers will track cardiovascular events over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Cleerly CAD Staging System (software that analyzes CT scans to stage coronary artery disease and guide treatment)
What this could lead to: If successful, this could show that using detailed imaging to guide heart disease prevention is more effective than relying on traditional risk factors like cholesterol and blood pressure.
What could go wrong: This is a large but early-stage pragmatic trial; the software-based approach may not reduce events more than standard care, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 7,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X prediabetes syndrome type 2 diabetes mellitus cardiovascular disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Metabolic syndrome Prediabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

123 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ace Research Institute - Monterey Park
RECRUITING

Monterey Park, California, 91754, United States
Ace Research Institute: Northridge
RECRUITING

Northridge, California, 91324, United States
Ace Research Institute: Northridge #2
RECRUITING

Northridge, California, 91325, United States
Advanced Heart and Vascular Institute of Hunterdon
RECRUITING

Flemington, New Jersey, 08822, United States
Aeres Clinical Research
RECRUITING

Laredo, Texas, 78041, United States
Aiyan Diabetes Center
RECRUITING

Augusta, Georgia, 30907, United States
Amicis Research: Beverly Hills
RECRUITING

Beverly Hills, California, 90211, United States
Amicis Research: Granada Hills
RECRUITING

Granada Hills, California, 91324, United States
Amicis Research: Newhall
RECRUITING

Newhall, California, 91321, United States
Amicis Research: Northridge
RECRUITING

Northridge, California, 91324, United States
Amicis Research: San Fernando
RECRUITING

San Fernando, California, 91306, United States
Amicis Research: Valencia
RECRUITING

Valencia, California, 91355, United States
Apex Research
RECRUITING

Cross City, Florida, 32628, United States
Ascension DePaul Services Research Center
RECRUITING

New Orleans, Louisiana, 70127, United States
Ascension Sacred Heart
RECRUITING

Pensacola, Florida, 32504, United States
Ascension St. John - Jane Phillips Medical Center
RECRUITING

Tulsa, Oklahoma, 74104, United States
Atlantis Clinical Research, LLC
RECRUITING

Miami, Florida, 33173, United States
Baptist Health Miami Cardiac and Vascular Institute
RECRUITING

Miami, Florida, 33173, United States
BioPhase Research
RECRUITING

Miami, Florida, 33137, United States
Boeson Research Fort Missoula
RECRUITING

Missoula, Montana, 59804, United States
Boeson Research Kalispell
RECRUITING

Kalispell, Montana, 59901, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Bryan Heart
RECRUITING

Lincoln, Nebraska, 68506, United States
Cape Fear Valley Health System (Javara Inc.)
RECRUITING

Fayetteville, North Carolina, 28304, United States
Capital Area Research
RECRUITING

Camp Hill, Pennsylvania, 17011, United States
CardioVoyage, LLC
RECRUITING

Greenville, Texas, 75402, United States
Cardiovascular Institute of San Diego
RECRUITING

Chula Vista, California, 91911, United States
Cardiovascular Research Foundation of Southern California
RECRUITING

Beverly Hills, California, 90210, United States
Care Institute- High Desert
RECRUITING

Meridian, Idaho, 83642, United States
Chandler Clinical Trials
RECRUITING

Chandler, Arizona, 85224, United States
Charleston Area Medical Center
RECRUITING

Charleston, West Virginia, 25304, United States
Chemidox Clinical Trials
RECRUITING

Lancaster, California, 93534, United States
Chippenham Johnston Willis Medical Center
RECRUITING

Richmond, Virginia, 23225, United States
Clindove Research
RECRUITING

Brooklyn, New York, 11221, United States
Clinical Research Center of Florida
RECRUITING

Pompano Beach, Florida, 33060, United States
Community DPC
RECRUITING

Cleveland, Tennessee, 37312, United States
Concierge Clinical Trials
RECRUITING

Valley Village, California, 91607, United States
DC Clinical Research
RECRUITING

Lewisville, Texas, 75057, United States
Duke University Hospital
RECRUITING

Durham, North Carolina, 27701, United States
Durham Veterans Affairs Medical Center (Durham VAMC)
RECRUITING

Durham, North Carolina, 27705, United States
Emory University
RECRUITING

Dunwoody, Georgia, 30338, United States
Evergreen Clinical Trials
RECRUITING

Norcross, Georgia, 30092, United States
Evolution Research Center
RECRUITING

Hialeah, Florida, 33012, United States
Farma Medical Inc.
RECRUITING

Miami, Florida, 33183, United States
Fiel Wellness Clinical Research LLC
RECRUITING

Miami, Florida, 33135, United States
Flourish Bowie dba Flourish Research
RECRUITING

Bowie, Maryland, 20715, United States
Flourish Medical Research
RECRUITING

Boca Raton, Florida, 33434, United States
Franciscan Physician Network- Indiana Heart Physicians
RECRUITING

Indianapolis, Indiana, 46237, United States
Gadolin Research
RECRUITING

Beaumont, Texas, 77702, United States
Gulf Coast Clinical Research, LLC
RECRUITING

Houston, Texas, 77070, United States
HALO Diagnostics
RECRUITING

Indian Wells, California, 92210, United States
Helium Research Group
RECRUITING

Houston, Texas, 77004, United States
Hendrick Health
RECRUITING

Abilene, Texas, 79601, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Hightower Clinical
RECRUITING

Oklahoma City, Oklahoma, 73007, United States
Holy Name Medical Center
RECRUITING

Teaneck, New Jersey, 07666, United States
Indiana Medical Research Institute
RECRUITING

Indianapolis, Indiana, 46202, United States
KUR Research at CMP
RECRUITING

Columbia, Maryland, 21045, United States
Kalo Clinical Research
NOT_YET_RECRUITING

West Valley City, Utah, 84120, United States
Kelsey Research Foundation
RECRUITING

Houston, Texas, 77025, United States
Loma Linda University Health
RECRUITING

Loma Linda, California, 92354, United States
Long Beach Research Institute
RECRUITING

Long Beach, California, 90805, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
RECRUITING

Torrance, California, 90502, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Medical Research International, LLC
RECRUITING

Oklahoma City, Oklahoma, 73109, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
MercyOne Iowa Heart Center
RECRUITING

West Des Moines, Iowa, 50266, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Mount Sinai
RECRUITING

New York, New York, 10029, United States
Mount Sinai West
RECRUITING

New York, New York, 10019, United States
New Access Research and Medical Center
RECRUITING

Miami, Florida, 33186, United States
Noble Clinical Research
RECRUITING

Tucson, Arizona, 85704, United States
North Dallas Research Associates - Kerlo Network
RECRUITING

McKinney, Texas, 75069, United States
Northridge Clinical Trials
ACTIVE_NOT_RECRUITING

Northridge, California, 91325, United States
Northshore University Health System
RECRUITING

Glenview, Illinois, 60026, United States
Northwell Health Northern Westchester Hospital
RECRUITING

Mount Kisco, New York, 10549, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
Optum- Long Island NY
RECRUITING

Lake Success, New York, 11042, United States
Peachtree Clinical Solutions - Noir Research Collective
RECRUITING

Powder Springs, Georgia, 30127, United States
Privia Medical Group Georgia - Thomasville (Javara)
RECRUITING

Thomasville, Georgia, 31792, United States
Privia Medical Group Georgia LLC -Fayetteville (Javara)
RECRUITING

Fayetteville, Georgia, 30214, United States
Privia Medical Group Georgia, LLC (Javara Inc.)
RECRUITING

Savannah, Georgia, 31406, United States
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
RECRUITING

San Marcos, Texas, 78666, United States
Privia Medical Group- North Texas
RECRUITING

Stephenville, Texas, 76401, United States
Providence Regional Medical Center Everett
RECRUITING

Everett, Washington, 98201, United States
Quantum Clinical Trials
RECRUITING

Miami Beach, Florida, 33140, United States
Randomize Now, LLC - Noir Research Collective
RECRUITING

Riverdale, Georgia, 30296, United States
Randomize Now- Atlanta West
RECRUITING

Lithia Springs, Georgia, 30122, United States
Randomize Now-Burton Medical
RECRUITING

Macon, Georgia, 31210, United States
Rasaj Research
RECRUITING

Jackson Heights, New York, 11372, United States
Rutgers State University
RECRUITING

New Brunswick, New Jersey, 08901, United States
SMS Clinical Research
RECRUITING

Mesquite, Texas, 75149, United States
Saint Louis Heart and Vascular
RECRUITING

St Louis, Missouri, 63136, United States
Sanford Health
RECRUITING

Fargo, North Dakota, 58102, United States
Scottsdale Clinical Trials
RECRUITING

Scottsdale, Arizona, 85260, United States
Scripps Health
RECRUITING

La Jolla, California, 92037, United States
Southwest Medical Associates- Optum Nevada
RECRUITING

Las Vegas, Nevada, 89102, United States
St Elizabeth Health Care - CRI
RECRUITING

Edgewood, Kentucky, 41017, United States
St. Josephs (Intermountain Healthcare)
RECRUITING

Denver, Colorado, 80218, United States
Stanford Health Care
RECRUITING

Palo Alto, California, 94304, United States
Summa Health
RECRUITING

Akron, Ohio, 44304, United States
Sun City Research
RECRUITING

Sun City, Arizona, 85381, United States
Swift Clinical Research
RECRUITING

Brooklyn, New York, 11226, United States
The Methodist Hospital, DeBakey Cardiology Associates
RECRUITING

Houston, Texas, 77030, United States
The Valley Hospital
RECRUITING

Paramus, New Jersey, 07652, United States
TriStar Centennial Medical Center (HCA Health Care)
RECRUITING

Nashville, Tennessee, 37202, United States
Trinity Health Michigan Heart
RECRUITING

Ypsilanti, Michigan, 48917, United States
UF Health Jacksonville
RECRUITING

Jacksonville, Florida, 32209, United States
United Clinical Research
RECRUITING

Miami, Florida, 33155, United States
University of California- Irvine
RECRUITING

Orange, California, 92868, United States
University of Colorado
RECRUITING

Aurora, Colorado, 80045, United States
University of North Carolina at Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of South Florida
RECRUITING

Tampa, Florida, 33620, United States
University of Tennessee Medical Center
RECRUITING

Knoxville, Tennessee, 37920, United States
University of Washington
RECRUITING

Seattle, Washington, 98195, United States
UofL Health
RECRUITING

Louisville, Kentucky, 40202, United States
VA Palo Alto
RECRUITING

Palo Alto, California, 94304, United States
Valiance Clinical Research - Canoga Park
RECRUITING

Canoga Park, California, 91303, United States
Valiance Clinical Research - Tarzana
RECRUITING

Tarzana, California, 91356, United States
Valiance Clinical Research: Huntington Park
RECRUITING

Huntington Park, California, 90255, United States
Vector Clinical Trials
RECRUITING

Las Vegas, Nevada, 89128, United States
Virtua Health, Inc.
RECRUITING

Marlton, New Jersey, 08053, United States
Wake Forest University Health Sciences
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
West Clinical Research
ACTIVE_NOT_RECRUITING

Morehead City, North Carolina, 28557, United States

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