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

Launched by CLEERLY, INC. · Oct 31, 2023

Keywords

ClinConnect Summary

The TRANSFORM trial is a research study designed to compare two different approaches to help prevent heart problems in people who are at higher risk but do not currently have any symptoms of heart disease. One approach uses a specific system to stage coronary artery disease (CAD) to guide care, while the other focuses on managing known risk factors, such as diabetes or high blood pressure. The goal is to see if the staging system can lead to fewer heart-related events, like heart attacks or strokes, compared to the traditional risk factor-based care.

To be eligible for this study, participants should be men over 55 years old or women over 65 years old, and they must have type 2 diabetes requiring medication, prediabetes, or metabolic syndrome (a condition that includes a combination of risk factors like high blood pressure and obesity). Participants will need to have a device like a smartphone or tablet to communicate with a healthcare team. Those who have a history of heart disease or certain health issues might not be able to join. If you choose to participate, you can expect regular communication with a team of doctors who will provide personalized care based on your health needs throughout the trial.

Gender

ALL

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)