A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardi… (NCT06112418) | Clinical Trial Compass
RecruitingNot Applicable
A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
United States7,500 participantsStarted 2024-03-06
Plain-language summary
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 participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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):
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two approaches to preventing heart events — one based on 'Cleerly staging' using coronary imaging and one based on traditional risk factors like blood sugar and cholesterol — which approach am I currently being managed with, and could it be worth discussing whether the other approach might catch something we're missing?
2Since this trial is listed as 'Phase NA,' meaning it's comparing two existing care strategies rather than testing a brand-new drug, how does that affect what's already known about the safety of each approach, and are there any downsides to the Cleerly coronary imaging scans I should be aware of?
3I have type 2 diabetes or prediabetes, which puts me at higher cardiovascular risk — given that, how would my doctor decide whether my risk level makes me a good candidate to discuss this trial with the research team?
4The trial is actively recruiting right now, so if my doctor thinks this could be relevant for me, what would participation actually involve in terms of extra visits, imaging tests, or changes to my current treatment plan?
5If I chose not to explore this trial, what is the current standard-of-care approach my doctor would use to monitor and reduce my cardiovascular risk given my diabetes or metabolic syndrome diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.
Timeframe: Through study completion- an average of 3.5 years
. 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