RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to prevent heart and blood vessel problems: care based on the stage of heart artery disease and care based on risk factors. It is for older adults at higher risk who have no known heart or blood vessel disease causing symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written or electronic consent to join.
  • Be a man older than 55 or a woman older than 65.
  • Have type 2 diabetes treated with medicine, prediabetes, or metabolic syndrome.
  • Prediabetes means a recent HbA1c of 5.7–6.4% or fasting blood sugar of 100–125 mg/dL. HbA1c measures average blood sugar.
  • Metabolic syndrome means having more than 3 of these: high body weight or waist size, high blood fats called triglycerides, low HDL ('good') cholesterol, high blood pressure, or high blood sugar. Study-specific limits apply.
  • Have a smartphone, tablet, or computer to contact the heart care team that manages medicines for the personalized care group.

Who can't join

  • Past heart attack, chest pain from heart disease, stroke from a blocked blood vessel, or leg pain from poor blood flow. Other heart disease being treated by a heart doctor, such as an irregular heartbeat or heart failure, also rules you out.
  • Past artery-opening treatment for plaque buildup, or a planned procedure to restore blood flow through an artery.
  • Cannot safely complete a CCTA—a CT scan of the heart arteries—or are likely to have a scan that cannot be read clearly.
  • Kidney filtering test (eGFR) below 60, allergy to iodine-based scan dye, or past kidney damage from scan dye.
  • Untreated overactive thyroid, thyroid cancer within the past 5 years, or planned radioactive iodine treatment.
  • Weight over 300 pounds or the scanner's weight limit, or inability to hold your breath for more than 10 seconds.
  • An active irregular heartbeat with a poorly controlled rate above 80 beats per minute, or inability to safely take a beta blocker or nitroglycerin on scan day.
  • The study doctor finds participation unsuitable, such as severe narrowing of the main heart artery, another illness with expected survival under 3 years, or likely trouble following study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (125)

AZ

CA

CO

  • University of Colorado · Aurora, CO 80045Steve Simon · Study contactSteve Simon, MD · Principal investigatorMore trials in Aurora
  • St. Josephs (Intermountain Healthcare) · Denver, CO 80218Christopher Angus, MD · Study contactMore trials in Denver

FL

GA

  • Aiyan Diabetes Center · Augusta, GA 30907Anthony D. Turner, MD · Study contactMore trials in Augusta
  • Emory University · Dunwoody, GA 30338Ambar Kulshreshtha, MD · Study contactMore trials in Dunwoody
  • Privia Medical Group Georgia LLC -Fayetteville (Javara) · Fayetteville, GA 30214Charlotte Grayson Mathis, MD · Study contactMore trials in Fayetteville
  • Randomize Now- Atlanta West · Lithia Springs, GA 30122Millard Collier Jr., MD · Study contactMore trials in Lithia Springs
  • Randomize Now-Burton Medical · Macon, GA 31210Frederick Burton, MD · Study contactMore trials in Macon
  • Evergreen Clinical Trials · Norcross, GA 30092Dmitriy Pelishev, MD · Study contactMore trials in Norcross
  • Peachtree Clinical Solutions - Noir Research Collective · Powder Springs, GA 30127Karan Raghavan, MD · Study contactMore trials in Powder Springs
  • Randomize Now, LLC - Noir Research Collective · Riverdale, GA 30296Claire K. Willie, MD · Study contactMore trials in Riverdale
  • Privia Medical Group Georgia, LLC (Javara Inc.) · Savannah, GA 31406Thomas G. Moriarity, MD · Study contactMore trials in Savannah
  • Privia Medical Group Georgia - Thomasville (Javara) · Thomasville, GA 31792William L. Cooper, MD · Study contactMore trials in Thomasville

IA

ID

IL

IN

KY

LA

MA

  • Massachusetts General Hospital · Boston, MA 02114Pradeep Natarajan, MD · Study contactMore trials in Boston
  • Brigham and Women's Hospital · Boston, MA 02115Ron Blankstein, MD · Study contactMore trials in Boston

MD

MI

MN

MO

MT

NC

ND

NE

NJ

NV

NY

OH

OK

PA

SC

TN

TX

UT

VA

  • Chippenham Johnston Willis Medical Center · Richmond, VA 23225Michael Arcarese, MD · Study contactMore trials in Richmond

WA

  • Providence Regional Medical Center Everett · Everett, WA 98201Xiaojing Jennie Shen, MD · Study contactMore trials in Everett
  • University of Washington · Seattle, WA 98195Kelley Branch, MD · Study contactMore trials in Seattle

WV