A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
Recruiting · NCT06112418 · Interventional (participants receive a specific treatment) · Lead sponsor: Cleerly, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
The Cleerly CAD Staging System
What this trial 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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
60 locations listed across 33 US states.
- Chandler Clinical Trials - Chandler, Arizona, United States
- Scottsdale Clinical Trials - Scottsdale, Arizona, United States
- Sun City Research - Sun City, Arizona, United States
- Noble Clinical Research - Tucson, Arizona, United States
- Cardiovascular Research Foundation of Southern California - Beverly Hills, California, United States
- Amicis Research: Beverly Hills - Beverly Hills, California, United States
- Valiance Clinical Research - Canoga Park - Canoga Park, California, United States
- Cardiovascular Institute of San Diego - Chula Vista, California, United States
- Amicis Research: Granada Hills - Granada Hills, California, United States
- Valiance Clinical Research: Huntington Park - Huntington Park, California, United States
- HALO Diagnostics - Indian Wells, California, United States
- Scripps Health - La Jolla, California, United States
- Chemidox Clinical Trials - Lancaster, California, United States
- Loma Linda University Health - Loma Linda, California, United States
- Long Beach Research Institute - Long Beach, California, United States
- Ace Research Institute - Monterey Park - Monterey Park, California, United States
- Amicis Research: Newhall - Newhall, California, United States
- Ace Research Institute: Northridge - Northridge, California, United States
- Amicis Research: Northridge - Northridge, California, United States
- Ace Research Institute: Northridge #2 - Northridge, California, United States
- Northridge Clinical Trials - Northridge, California, United States
- University of California- Irvine - Orange, California, United States
- Stanford Health Care - Palo Alto, California, United States
- VA Palo Alto - Palo Alto, California, United States
- Amicis Research: San Fernando - San Fernando, California, United States
- Valiance Clinical Research - Tarzana - Tarzana, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center - Torrance, California, United States
- Amicis Research: Valencia - Valencia, California, United States
- Concierge Clinical Trials - Valley Village, California, United States
- University of Colorado - Aurora, Colorado, United States
- St. Josephs (Intermountain Healthcare) - Denver, Colorado, United States
- Flourish Medical Research - Boca Raton, Florida, United States
- Apex Research - Cross City, Florida, United States
- Evolution Research Center - Hialeah, Florida, United States
- UF Health Jacksonville - Jacksonville, Florida, United States
- Fiel Wellness Clinical Research LLC - Miami, Florida, United States
- BioPhase Research - Miami, Florida, United States
- United Clinical Research - Miami, Florida, United States
- Atlantis Clinical Research, LLC - Miami, Florida, United States
- Baptist Health Miami Cardiac and Vascular Institute - Miami, Florida, United States
- Farma Medical Inc. - Miami, Florida, United States
- New Access Research and Medical Center - Miami, Florida, United States
- Quantum Clinical Trials - Miami Beach, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Clinical Research Center of Florida - Pompano Beach, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Aiyan Diabetes Center - Augusta, Georgia, United States
- Emory University - Dunwoody, Georgia, United States
- Privia Medical Group Georgia LLC -Fayetteville (Javara) - Fayetteville, Georgia, United States
- Randomize Now- Atlanta West - Lithia Springs, Georgia, United States
- Randomize Now-Burton Medical - Macon, Georgia, United States
- Evergreen Clinical Trials - Norcross, Georgia, United States
- Peachtree Clinical Solutions - Noir Research Collective - Powder Springs, Georgia, United States
- Randomize Now, LLC - Noir Research Collective - Riverdale, Georgia, United States
- Privia Medical Group Georgia, LLC (Javara Inc.) - Savannah, Georgia, United States
- Privia Medical Group Georgia - Thomasville (Javara) - Thomasville, Georgia, United States
- Care Institute- High Desert - Meridian, Idaho, United States
- Northwestern University - Chicago, Illinois, United States
- Northshore University Health System - Glenview, Illinois, United States
- Indiana Medical Research Institute - Indianapolis, Indiana, United States
Showing 60 of 125 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →