Personalized therapy management for patients with suspected coronary artery disease
A Randomized Comparison of Personalized Management for Medical and Interventional Therapy Based On Coronary Atherosclerotic Plaque Versus Usual Care for Symptomatic Patients With Suspicion of CAD
This study tests a new personalized treatment plan using AI and CT scans for people who might have coronary artery disease to see if it helps them get better care compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cleerly, Inc. Industry-sponsored |
| Locations | 21 sites (Mobile, Alabama and 20 other locations) |
| Trial ID | NCT06713239 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a personalized management strategy for symptomatic patients suspected of having coronary artery disease (CAD) by utilizing AI-enabled quantitative software to assess coronary atherosclerotic plaque through CT imaging. Participants will be randomly assigned to receive either this personalized approach or usual care based on current AHA/ACC guidelines. The study aims to improve diagnostic certainty, control of CAD risk factors, and the efficiency of referrals for invasive coronary angiography (ICA) and appropriate percutaneous coronary intervention (PCI).
Who should consider this trial
Good fit: Ideal candidates are symptomatic individuals over 18 years old who have a suspicion of coronary artery disease and are referred for elective diagnostic testing.
Not a fit: Patients with a known history of obstructive CAD or those currently undergoing treatment beyond primary prevention guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better management of coronary artery disease, ultimately improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic strategies for CAD, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 18 years * Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test) Exclusion Criteria: * LDL \< 100 mg/dL * Currently or previously treated beyond primary prevention guidelines * Suspected acute coronary syndrome or otherwise unstable clinical status * Planned cardiovascular procedure (e.g. coronary angiography, cardiac surgery, non-coronary vascular procedure) * Noninvasive or invasive CV testing for CAD within 1 year (e.g. invasive coronary angiography (ICA), coronary CT angiography (CCTA) including calcium scoring) * Known history of obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%) * Known EF ≤40% or other moderate to severe valvular or congenital cardiac disease * Contraindications to CCTA
Where this trial is running
Mobile, Alabama and 20 other locations
- Cardiology Associates of Mobile — Mobile, Alabama, United States (Recruiting)
- Valiance Clinical Research- Huntington Park — Huntington Park, California, United States (Recruiting)
- Cardiovascular Institute of San Diego — San Diego, California, United States (Recruiting)
- Valiance Clinical Research- Tarzana — Tarzana, California, United States (Recruiting)
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (Recruiting)
- Intermountain Health Saint Joseph Hospital — Broomfield, Colorado, United States (Recruiting)
- Tampa Cardiovascular Interventions and Research — Tampa, Florida, United States (Recruiting)
- Flourish Research — Winter Park, Florida, United States (Recruiting)
- Endeavor Health Clinical Operations — Evanston, Illinois, United States (Recruiting)
- MercyOne Des Moines Medical Center — West Des Moines, Iowa, United States (Recruiting)
- Saint Elizabeth Medical Center — Edgewood, Kentucky, United States (Recruiting)
- Tulane University — New Orleans, Louisiana, United States (Recruiting)
- Flourish- Bowie — Bowie, Maryland, United States (Recruiting)
- St. Louis Heart and Vascular — Bridgeton, Missouri, United States (Recruiting)
- Advanced Heart and Vascular Institute of Hunterdon — Flemington, New Jersey, United States (Recruiting)
- Capital Cardiology Associates — Albany, New York, United States (Recruiting)
- University of Cincinnatti — Cincinnati, Ohio, United States (Recruiting)
- Oklahoma Cardiovascular Research Group — Oklahoma City, Oklahoma, United States (Recruiting)
- The University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
- Medical City Fort Worth Hospital — Fort Worth, Texas, United States (Recruiting)
- Chippenham and Johnston Willis Hospitals — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Todd Villines, MD — University of Virginia
- Study coordinator: Ryann Sardinia
- Email: ryann.sardinia@cleerlyhealth.com
- Phone: 7207398191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.