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

Cleerly, Inc. · with CPC Clinical Research · NCT06112418

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
7500
US sites recruiting
122
Study start
March 6, 2024
Record last updated
September 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: The Cleerly CAD Staging System

Conditions: Diabetes Mellitus, Type 2; PreDiabetes; Metabolic Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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
  • 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

Exclusion Criteria

  • 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
  • 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)

Recruiting US locations

  • Chandler Clinical Trials

    Chandler, AZ 85224

    Site contact: Muhammad Salim, MD

  • Scottsdale Clinical Trials

    Scottsdale, AZ 85260

    Site contact: Todd Dreitzler, MD

  • Sun City Research

    Sun City, AZ 85381

    Site contact: Juan Rodriguez, MD

  • Noble Clinical Research

    Tucson, AZ 85704

    Site contact: Roxana Rodriguez, MD

  • Cardiovascular Research Foundation of Southern California

    Beverly Hills, CA 90210

    Site contact: Ronald P. Karlsberg, MD

  • Amicis Research: Beverly Hills

    Beverly Hills, CA 90211

    Site contact: Michael Levine, MD

  • Valiance Clinical Research - Canoga Park

    Canoga Park, CA 91303

    Site contact: Rami Shaarawy

  • Cardiovascular Institute of San Diego

    Chula Vista, CA 91911

    Site contact: Milind D. Parikh, MD

  • Amicis Research: Granada Hills

    Granada Hills, CA 91324

    Site contact: Pascal Dabel, MD

  • Valiance Clinical Research: Huntington Park

    Huntington Park, CA 90255

    Site contact: Philip Kim, MD

  • HALO Diagnostics

    Indian Wells, CA 92210

    Site contact: John F. Feller, MD

  • Scripps Health

    La Jolla, CA 92037

    Site contact: Elizabeth Epstein, MD

  • Chemidox Clinical Trials

    Lancaster, CA 93534

    Site contact: Pamela Dewar-DeSilva, MD

  • Loma Linda University Health

    Loma Linda, CA 92354

    Site contact: Purvi Parwani, MD

  • Long Beach Research Institute

    Long Beach, CA 90805

    Site contact: Ashley Duzik, MD

  • Ace Research Institute - Monterey Park

    Monterey Park, CA 91754

    Site contact: Yu-Hsiang Sam Lee, MD

  • Amicis Research: Newhall

    Newhall, CA 91321

    Site contact: Thuong Vo, MD

  • Ace Research Institute: Northridge

    Northridge, CA 91324

    Site contact: Richard Park, MD

  • Amicis Research: Northridge

    Northridge, CA 91324

    Site contact: Nana Barseghian, MD

  • Ace Research Institute: Northridge #2

    Northridge, CA 91325

    Site contact: William Y. Josephson, MD

  • University of California- Irvine

    Orange, CA 92868

    Site contact: Ailin Barseghian El-Farra, MD

  • Stanford Health Care

    Palo Alto, CA 94304

    Site contact: Sandra Tsai, MD

  • VA Palo Alto

    Palo Alto, CA 94304

    Site contact: Shriram Nallamshetty, MD

  • Amicis Research: San Fernando

    San Fernando, CA 91306

    Site contact: Farid Yasharpour, MD

  • Valiance Clinical Research - Tarzana

    Tarzana, CA 91356

    Site contact: Harpreet Singh, MD

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

    Torrance, CA 90502

    Site contact: Suvasini Lakshmanan, MD

  • Amicis Research: Valencia

    Valencia, CA 91355

    Site contact: Dennis Lewis, MD

  • Concierge Clinical Trials

    Valley Village, CA 91607

    Site contact: Neal R. Cutler, MD

  • University of Colorado

    Aurora, CO 80045

    Site contact: Steve Simon

  • St. Josephs (Intermountain Healthcare)

    Denver, CO 80218

    Site contact: Christopher Angus, MD

  • Flourish Medical Research

    Boca Raton, FL 33434

    Site contact: Michael Hafran, MD

  • Apex Research

    Cross City, FL 32628

    Site contact: Tamir Salmani, MD

  • Evolution Research Center

    Hialeah, FL 33012

    Site contact: Riquel Gonzalez, MD

  • UF Health Jacksonville

    Jacksonville, FL 32209

    Site contact: Luis Ortega Paz, MD

  • Fiel Wellness Clinical Research LLC

    Miami, FL 33135

    Site contact: Osvaldo Caroma, MD

  • BioPhase Research

    Miami, FL 33137

    Site contact: Julie Cadet-Plassman, MD

  • United Clinical Research

    Miami, FL 33155

    Site contact: Teresa B. Alfonso, MD

  • Atlantis Clinical Research, LLC

    Miami, FL 33173

    Site contact: Leyvi Alvarado Miranda, MD

  • Baptist Health Miami Cardiac and Vascular Institute

    Miami, FL 33173

    Site contact: Jonathan Fialkow, MD

  • Farma Medical Inc.

    Miami, FL 33183

    Site contact: Ingrid Fernandez-Milian, MD

  • New Access Research and Medical Center

    Miami, FL 33186

    Site contact: Sander Fernandez, MD

  • Quantum Clinical Trials

    Miami Beach, FL 33140

    Site contact: Christopher A. Fayeghi, MD

  • Ascension Sacred Heart

    Pensacola, FL 32504

    Site contact: Rohit Amin, MD

  • Clinical Research Center of Florida

    Pompano Beach, FL 33060

    Site contact: Howard S. Koch, MD

  • University of South Florida

    Tampa, FL 33620

    Site contact: Shone Almeida, MD

  • Aiyan Diabetes Center

    Augusta, GA 30907

    Site contact: Anthony D. Turner, MD

  • Emory University

    Dunwoody, GA 30338

    Site contact: Ambar Kulshreshtha, MD

  • Privia Medical Group Georgia LLC -Fayetteville (Javara)

    Fayetteville, GA 30214

    Site contact: Charlotte Grayson Mathis, MD

  • Randomize Now- Atlanta West

    Lithia Springs, GA 30122

    Site contact: Millard Collier Jr., MD

  • Randomize Now-Burton Medical

    Macon, GA 31210

    Site contact: Frederick Burton, MD

  • Evergreen Clinical Trials

    Norcross, GA 30092

    Site contact: Dmitriy Pelishev, MD

  • Peachtree Clinical Solutions - Noir Research Collective

    Powder Springs, GA 30127

    Site contact: Karan Raghavan, MD

  • Randomize Now, LLC - Noir Research Collective

    Riverdale, GA 30296

    Site contact: Claire K. Willie, MD

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

    Savannah, GA 31406

    Site contact: Thomas G. Moriarity, MD

  • Privia Medical Group Georgia - Thomasville (Javara)

    Thomasville, GA 31792

    Site contact: William L. Cooper, MD

  • Care Institute- High Desert

    Meridian, ID 83642

    Site contact: David A. Hinchman, MD

  • Northwestern University

    Chicago, IL 60611

    Site contact: Paul C. Cremer, MD

  • Northshore University Health System

    Glenview, IL 60026

    Site contact: Amit K. Pursnani, MD

  • Indiana Medical Research Institute

    Indianapolis, IN 46202

    Site contact: Arshad P. Malik

  • Franciscan Physician Network- Indiana Heart Physicians

    Indianapolis, IN 46237

    Site contact: Ryan P Daly, MD

+ 62 more on the official record.

Study contacts (from the official record)

  • Ryann Sardinia · 7207398191 · ryann.sardinia@cleerlyhealth.com
  • Ashley Dunham, PhD · 7207398191 · ashley.dunham@cleerlyhealth.com
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A Randomized Comparison of Stage-Based Care Versus Risk… (NCT06112418) | Bored Studies