Stage-Based Care vs Risk Factor-Based Care for Heart Health

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

Recruiting N/A Interventional Study
Diabetes Mellitus, Type 2 PreDiabetes Metabolic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
55 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
7,500 (estimated)
Sponsor
Cleerly, Inc. · Industry
Who this trial is looking for

This trial is looking for older adults with diabetes or risk factors for heart disease. Participants will be randomly assigned to receive different types of care to see which approach is better at preventing heart problems.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 55 or older if male, or 65 or older if female.
  • I have type 2 diabetes that needs medication, prediabetes, or metabolic syndrome.
  • I can use a device to communicate with the care team.
  • I have provided my consent to participate.

You may not be able to join if

  • I have a history of heart disease or related conditions.
  • I have planned heart surgery.
  • I cannot safely undergo a specific heart scan.
  • I weigh more than 300 lbs.
  • I have uncontrolled heart rhythm problems.
  • I can't hold my breath for more than 10 seconds.
  • I have a serious health issue that might limit my life expectancy.
  • I am not suitable for this trial as determined by the investigator.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

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. M…
Contacts

Ryann Sardinia

7207398191

ryann.sardinia@cleerlyhealth.com

CONTACT

Ashley Dunham, PhD

7207398191

ashley.dunham@cleerlyhealth.com

CONTACT