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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID: NCT06112418
Run by: Cleerly, Inc.
People needed: 7500
Starts: 2024-03-06
Expected to finish: 2029-03-05
Last updated by the study team: 2026-07-10

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Chandler Clinical Trials — Chandler, Arizona, United States (enrolling)
Sun City Research — Sun City, Arizona, United States (enrolling)
Noble Clinical Research — Tucson, Arizona, United States (enrolling)
Scottsdale Clinical Trials — Scottsdale, Arizona, United States (enrolling)
Amicis Research: Beverly Hills — Beverly Hills, California, United States (enrolling)
Valiance Clinical Research - Canoga Park — Canoga Park, California, United States (enrolling)
Cardiovascular Institute of San Diego — Chula Vista, California, United States (enrolling)
Amicis Research: Granada Hills — Granada Hills, California, United States (enrolling)
Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States (enrolling)
HALO Diagnostics — Indian Wells, California, United States (enrolling)
Scripps Health — La Jolla, California, United States (enrolling)
Chemidox Clinical Trials — Lancaster, California, United States (enrolling)
Loma Linda University Health — Loma Linda, California, United States (enrolling)
Long Beach Research Institute — Long Beach, California, United States (enrolling)
Ace Research Institute - Monterey Park — Monterey Park, California, United States (enrolling)
Amicis Research: Newhall — Newhall, California, United States (enrolling)
Ace Research Institute: Northridge — Northridge, California, United States (enrolling)
Amicis Research: Northridge — Northridge, California, United States (enrolling)
Ace Research Institute: Northridge #2 — Northridge, California, United States (enrolling)
Valiance Clinical Research: Huntington Park — Huntington Park, California, United States (enrolling)
University of California- Irvine — Orange, California, United States (enrolling)
Stanford Health Care — Palo Alto, California, United States (enrolling)
VA Palo Alto — Palo Alto, California, United States (enrolling)
Amicis Research: San Fernando — San Fernando, California, United States (enrolling)
Valiance Clinical Research - Tarzana — Tarzana, California, United States (enrolling)

Full record on ClinicalTrials.gov

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