AzTrials
AzTrials

Diabetes Mellitus, Type 2TRANSFORMNCT06112418

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

A study testing The Cleerly CAD Staging System in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Cleerly, Inc. at 125 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
What is being tested?
The Cleerly CAD Staging System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,500 participants
Where
125 sitesUnited States
Study dates
6 Mar 2024to 5 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Provided electronic or written informed consent
  • Men > 55, women > 65 years of age
  • 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
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  • 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%
  • Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group

Who cannot join

  • 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
  • Planned arterial revascularization
  • Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:
  • 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)
  • 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.
  • Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
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  • Weight > 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site
  • Inability to hold breath for > 10 seconds
  • 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)
  • Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA
  • Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
  • 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)

Trial locations and contacts

125 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ryann Sardinia contact

7207398191

ryann.sardinia@cleerlyhealth.com

Ashley Dunham, PhD contact

7207398191

ashley.dunham@cleerlyhealth.com

125 sites in 1 country

United States125 sites, 123 recruiting

  • Hendrick Health

    Abilene, Texas, 79601

    Ren Zhang, MD

    Recruiting

  • Summa Health

    Akron, Ohio, 44304

    Wissam Alajaji, MD

    Recruiting

  • Aiyan Diabetes Center

    Augusta, Georgia, 30907

    Anthony D. Turner, MD

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Steve Simon

    Steve Simon, MD

    Recruiting

  • Gadolin Research

    Beaumont, Texas, 77702

    John T Fowler, MD

    Recruiting

  • Cardiovascular Research Foundation of Southern California

    Beverly Hills, California, 90210

    Ronald P. Karlsberg, MD

    Recruiting

  • Amicis Research: Beverly Hills

    Beverly Hills, California, 90211

    Michael Levine, MD

    Recruiting

  • Flourish Medical Research

    Boca Raton, Florida, 33434

    Michael Hafran, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Pradeep Natarajan, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Ron Blankstein, MD

    Recruiting

  • Flourish Bowie dba Flourish Research

    Bowie, Maryland, 20715

    Sara Collins, MD

    Recruiting

  • Clindove Research

    Brooklyn, New York, 11221

    Nelly Cohen, MD

    Recruiting

  • Swift Clinical Research

    Brooklyn, New York, 11226

    Manoj Dalmia, MD

    Recruiting

  • Capital Area Research

    Camp Hill, Pennsylvania, 17011

    Venkatesh Nadar, MD

    Recruiting

  • Valiance Clinical Research - Canoga Park

    Canoga Park, California, 91303

    Rami Shaarawy

    Recruiting

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

    Muhammad Salim, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Matthew Cavender, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Marc-Andre Cornier, MD

    Recruiting

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

    Sarah Rinehart, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Paul C. Cremer, MD

    Recruiting

  • Cardiovascular Institute of San Diego

    Chula Vista, California, 91911

    Milind D. Parikh, MD

    Recruiting

  • Community DPC

    Cleveland, Tennessee, 37312

    Carlton Volberg, MD

    Recruiting

  • KUR Research at CMP

    Columbia, Maryland, 21045

    William Saway, MD

    Recruiting

  • Apex Research

    Cross City, Florida, 32628

    Tamir Salmani, MD

    Recruiting

  • St. Josephs (Intermountain Healthcare)

    Denver, Colorado, 80218

    Christopher Angus, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Cori E Russell, MD

    Recruiting

  • Emory University

    Dunwoody, Georgia, 30338

    Ambar Kulshreshtha, MD

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27701

    William Yancy, MD

    Recruiting

  • Durham Veterans Affairs Medical Center (Durham VAMC)

    Durham, North Carolina, 27705

    Hayden Bosworth, MD

    Recruiting

  • St Elizabeth Health Care - CRI

    Edgewood, Kentucky, 41017

    Erica Pivato, MD

    Recruiting

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

    Xiaojing Jennie Shen, MD

    Recruiting

  • Sanford Health

    Fargo, North Dakota, 58102

    David J. Clardy, MD

    Recruiting

  • Privia Medical Group Georgia LLC -Fayetteville (Javara)

    Fayetteville, Georgia, 30214

    Charlotte Grayson Mathis, MD

    Recruiting

  • Cape Fear Valley Health System (Javara Inc.)

    Fayetteville, North Carolina, 28304

    Nafisa Saleem, MD

    Recruiting

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey, 08822

    Andrey Espinoza, MD

    Recruiting

  • Northshore University Health System

    Glenview, Illinois, 60026

    Amit K. Pursnani, MD

    Recruiting

  • Amicis Research: Granada Hills

    Granada Hills, California, 91324

    Pascal Dabel, MD

    Recruiting

  • CardioVoyage, LLC

    Greenville, Texas, 75402

    Marc Demyun, MD

    Recruiting

  • Evolution Research Center

    Hialeah, Florida, 33012

    Riquel Gonzalez, MD

    Recruiting

  • Helium Research Group

    Houston, Texas, 77004

    Ijeoma A. Ekeruo

    Recruiting

  • Kelsey Research Foundation

    Houston, Texas, 77025

    Rohan R Wagle, MD

    Recruiting

  • The Methodist Hospital, DeBakey Cardiology Associates

    Houston, Texas, 77030

    Sadeer Al-Kindi, MD

    Recruiting

  • Gulf Coast Clinical Research, LLC

    Houston, Texas, 77070

    Anjani Pandya, MD

    Recruiting

  • Valiance Clinical Research: Huntington Park

    Huntington Park, California, 90255

    Philip Kim, MD

    Recruiting

  • HALO Diagnostics

    Indian Wells, California, 92210

    John F. Feller, MD

    Recruiting

  • Indiana Medical Research Institute

    Indianapolis, Indiana, 46202

    Arshad P. Malik

    Recruiting

  • Franciscan Physician Network- Indiana Heart Physicians

    Indianapolis, Indiana, 46237

    Ryan P Daly, MD

    Recruiting

  • Rasaj Research

    Jackson Heights, New York, 11372

    Ammara Mushtaq, MD

    Recruiting

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

    Luis Ortega Paz, MD

    Recruiting

  • Boeson Research Kalispell

    Kalispell, Montana, 59901

    Justin Buls, MD

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Kashif A. Shaikh, MD

    Recruiting

  • Scripps Health

    La Jolla, California, 92037

    Elizabeth Epstein, MD

    Recruiting

  • Optum- Long Island NY

    Lake Success, New York, 11042

    Steven Goldberg, MD

    Recruiting

  • Chemidox Clinical Trials

    Lancaster, California, 93534

    Pamela Dewar-DeSilva, MD

    Recruiting

  • Aeres Clinical Research

    Laredo, Texas, 78041

    Amando Garza, MD

    Recruiting

  • Southwest Medical Associates- Optum Nevada

    Las Vegas, Nevada, 89102

    Tatiana O. Tsvetkova, MD

    Recruiting

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

    Bharat R. Mocherla, MD

    Recruiting

  • DC Clinical Research

    Lewisville, Texas, 75057

    Moiz M. Shafiq, MD

    Recruiting

  • Bryan Heart

    Lincoln, Nebraska, 68506

    Chad E. Travers, MD

    Recruiting

  • Randomize Now- Atlanta West

    Lithia Springs, Georgia, 30122

    Millard Collier Jr., MD

    Recruiting

  • Loma Linda University Health

    Loma Linda, California, 92354

    Purvi Parwani, MD

    Recruiting

  • Long Beach Research Institute

    Long Beach, California, 90805

    Ashley Duzik, MD

    Recruiting

  • UofL Health

    Louisville, Kentucky, 40202

    Shahab Ghafghazi, MD

    Recruiting

  • Randomize Now-Burton Medical

    Macon, Georgia, 31210

    Frederick Burton, MD

    Recruiting

  • Virtua Health, Inc.

    Marlton, New Jersey, 08053

    Mark T. Finch, MD

    Recruiting

  • North Dallas Research Associates - Kerlo Network

    McKinney, Texas, 75069

    Muhammad Akram Khan, MD

    Recruiting

  • Care Institute- High Desert

    Meridian, Idaho, 83642

    David A. Hinchman, MD

    Recruiting

  • SMS Clinical Research

    Mesquite, Texas, 75149

    Salma Saiger, MD

    Recruiting

  • Fiel Wellness Clinical Research LLC

    Miami, Florida, 33135

    Osvaldo Caroma, MD

    Recruiting

  • BioPhase Research

    Miami, Florida, 33137

    Julie Cadet-Plassman, MD

    Recruiting

  • United Clinical Research

    Miami, Florida, 33155

    Teresa B. Alfonso, MD

    Alfonso

    Recruiting

  • Atlantis Clinical Research, LLC

    Miami, Florida, 33173

    Leyvi Alvarado Miranda, MD

    Recruiting

  • Baptist Health Miami Cardiac and Vascular Institute

    Miami, Florida, 33173

    Jonathan Fialkow, MD

    Recruiting

  • Farma Medical Inc.

    Miami, Florida, 33183

    Ingrid Fernandez-Milian, MD

    Recruiting

  • New Access Research and Medical Center

    Miami, Florida, 33186

    Sander Fernandez, MD

    Recruiting

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

    Christopher A. Fayeghi, MD

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Michael D. Miedema, MD

    Recruiting

  • Boeson Research Fort Missoula

    Missoula, Montana, 59804

    Audrey Remmers, MD

    Recruiting

  • Ace Research Institute - Monterey Park

    Monterey Park, California, 91754

    Yu-Hsiang Sam Lee, MD

    Recruiting

  • West Clinical Research

    Morehead City, North Carolina, 28557

    Active, not recruiting

  • Northwell Health Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Margaret Andersen, MD

    Recruiting

  • TriStar Centennial Medical Center (HCA Health Care)

    Nashville, Tennessee, 37202

    David Huneycutt, MD

    Recruiting

  • Rutgers State University

    New Brunswick, New Jersey, 08901

    Sabahat Bokhari, MD

    Recruiting

  • Ascension DePaul Services Research Center

    New Orleans, Louisiana, 70127

    Kristen Thomas, MD

    Recruiting

  • Mount Sinai West

    New York, New York, 10019

    Waqas A Malick, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Solomon Bienstock, MD

    Recruiting

  • Amicis Research: Newhall

    Newhall, California, 91321

    Thuong Vo, MD

    Recruiting

  • Evergreen Clinical Trials

    Norcross, Georgia, 30092

    Dmitriy Pelishev, MD

    Recruiting

  • Ace Research Institute: Northridge

    Northridge, California, 91324

    Richard Park, MD

    Recruiting

  • Amicis Research: Northridge

    Northridge, California, 91324

    Nana Barseghian, MD

    Recruiting

  • Ace Research Institute: Northridge #2

    Northridge, California, 91325

    William Y. Josephson, MD

    Recruiting

  • Northridge Clinical Trials

    Northridge, California, 91325

    Active, not recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73007

    Faisal Latif, MD

    Recruiting

  • Medical Research International, LLC

    Oklahoma City, Oklahoma, 73109

    Joseph Grillo, MD

    Recruiting

  • University of California- Irvine

    Orange, California, 92868

    Ailin Barseghian El-Farra, MD

    Recruiting

  • Stanford Health Care

    Palo Alto, California, 94304

    Sandra Tsai, MD

    Recruiting

  • VA Palo Alto

    Palo Alto, California, 94304

    Shriram Nallamshetty, MD

    Recruiting

  • The Valley Hospital

    Paramus, New Jersey, 07652

    Himanshu Gupta, MD

    Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

    Rohit Amin, MD

    Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

    Howard S. Koch, MD

    Recruiting

  • Peachtree Clinical Solutions - Noir Research Collective

    Powder Springs, Georgia, 30127

    Karan Raghavan, MD

    Recruiting

  • Chippenham Johnston Willis Medical Center

    Richmond, Virginia, 23225

    Michael Arcarese, MD

    Recruiting

  • Randomize Now, LLC - Noir Research Collective

    Riverdale, Georgia, 30296

    Claire K. Willie, MD

    Recruiting

  • Amicis Research: San Fernando

    San Fernando, California, 91306

    Farid Yasharpour, MD

    Recruiting

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

    San Marcos, Texas, 78666

    Alan Lee, MD

    Recruiting

  • Privia Medical Group Georgia, LLC (Javara Inc.)

    Savannah, Georgia, 31406

    Thomas G. Moriarity, MD

    Recruiting

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

    Todd Dreitzler, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Kelley Branch, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Farhan M. Katchi, MD

    Recruiting

  • Saint Louis Heart and Vascular

    St Louis, Missouri, 63136

    Gil Vardi, MD

    Recruiting

  • Privia Medical Group- North Texas

    Stephenville, Texas, 76401

    Benjamin Marcum, MD

    Recruiting

  • Sun City Research

    Sun City, Arizona, 85381

    Juan Rodriguez, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33620

    Shone Almeida, MD

    Recruiting

  • Valiance Clinical Research - Tarzana

    Tarzana, California, 91356

    Harpreet Singh, MD

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

    Jaffar Raza, MD

    Recruiting

  • Privia Medical Group Georgia - Thomasville (Javara)

    Thomasville, Georgia, 31792

    William L. Cooper, MD

    Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

    Torrance, California, 90502

    Suvasini Lakshmanan, MD

    Recruiting

  • Noble Clinical Research

    Tucson, Arizona, 85704

    Roxana Rodriguez, MD

    Recruiting

  • Ascension St. John - Jane Phillips Medical Center

    Tulsa, Oklahoma, 74104

    Michael Megaly, MD

    Recruiting

  • Amicis Research: Valencia

    Valencia, California, 91355

    Dennis Lewis, MD

    Recruiting

  • Concierge Clinical Trials

    Valley Village, California, 91607

    Neal R. Cutler, MD

    Recruiting

  • MercyOne Iowa Heart Center

    West Des Moines, Iowa, 50266

    Enrico L. Martin, MD

    Recruiting

  • Kalo Clinical Research

    West Valley City, Utah, 84120

    William J. Walsh, MD

    Not yet recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Michael Shapiro, MD

    Recruiting

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan, 48917

    Ahmad Mizyed, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
The Cleerly CAD Staging System
Medical subject headings
Diabetes Mellitus, Type 2, Prediabetic State, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Cleerly CAD Staging SystemDevice

    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.

Study groups in NCT06112418
Study groupRoleWhat they receive
Risk Factor-Based CareNo interventionThe 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.
Cleerly Stage-Based CareExperimentalThe 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.
Receives: Device: The Cleerly CAD Staging System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.

    The primary endpoint is total (first and subsequent) events for the composite endpoint of CV death, myocardial infarction (MI), ischemic stroke, acute limb ischemia, clinically driven arterial revascularization, and hospitalization or urgent visit for heart failure.

    Measured: Through study completion- an average of 3.5 years

Secondary outcomes (5)

  1. The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.

    The secondary endpoints are time from randomization to first occurence of an event in the primary efficacy endpoint.

    Measured: Through study completion- an average of 3.5 years

  2. The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.

    The secondary endpoints are total occurences after randomization of the primary efficacy endpoing, kidney failure, sustained estimated glomerular filtration rate (eGFR) decrease >40% from baseline, and death from renal causes.

    Measured: Through study completion- an average of 3.5 years

  3. The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.

    The secondary endpoints are first and total occurrences after randomization of coronary death, MI, and urgent coronary revascularization.

    Measured: Through study completion- an average of 3.5 years

  4. The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.

    The secondary endpoints are time from randomization to first occurrence of MI or ischemic stroke.

    Measured: Through study completion- an average of 3.5 years

  5. The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.

    The secondary endpoints are time from randomization to all-cause death.

    Measured: Through study completion- an average of 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start6 Mar 2024
  3. Primary completion5 Mar 2029 (estimated)
  4. Study completion5 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, open blinded endpoint (PROBE), event-driven pragmatic trial
Masking
None (open label)
Enrolment
7,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112418
Sponsor's protocol ID
202302CPC
Acronym
TRANSFORM
Status last verified
Sep 2026
First submitted
2 Oct 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

    PubMed 35078371

  • Clerc OF, Fuchs TA, Stehli J, Benz DC, Grani C, Messerli M, Giannopoulos AA, Buechel RR, Luscher TF, Pazhenkottil AP, Kaufmann PA, Gaemperli O. Non-invasive screening for coronary artery disease in asymptomatic diabetic patients: a systematic review and meta-analysis of randomised controlled trials. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):838-846. doi: 10.1093/ehjci/jey014.

    PubMed 29452348

Questions about this trial

What is this clinical trial studying?

A study testing The Cleerly CAD Staging System in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Cleerly, Inc. at 125 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryann Sardinia (7207398191, ryann.sardinia@cleerlyhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06112418, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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