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A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD

Launched by CLEERLY, INC. · Nov 27, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The PARAMOUNT trial is studying a new way to manage patients who have symptoms suggesting coronary artery disease (CAD). Researchers want to see if using advanced imaging technology to assess plaque in the arteries can provide better diagnosis and treatment than the standard care currently used. This personalized approach could help doctors make more informed decisions about managing CAD risk factors and referring patients for further procedures, compared to the usual guidelines.

To participate, you need to be over 18 years old and have symptoms that raise concerns about CAD, such as chest pain or shortness of breath. However, if you have certain conditions like very low cholesterol levels, a history of severe heart disease, or have had certain heart tests in the last year, you might not be eligible. If you join the trial, you can expect regular check-ups and assessments to monitor your heart health and treatment plan. Overall, this study aims to improve how doctors care for patients at risk of CAD.

Gender

ALL

Eligibility 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

About Cleerly, Inc.

Cleerly, Inc. is a pioneering healthcare technology company dedicated to transforming cardiovascular disease management through advanced imaging and diagnostic solutions. By leveraging cutting-edge artificial intelligence and machine learning, Cleerly develops innovative tools that enhance the accuracy of atherosclerosis detection and characterization. The company’s commitment to improving patient outcomes is reflected in its robust portfolio of clinical trials and research initiatives, aimed at providing healthcare professionals with actionable insights to guide personalized treatment strategies. Cleerly's mission is to empower clinicians and patients alike with comprehensive data, ultimately driving a paradigm shift in cardiovascular care.

Locations

Albany, New York, United States

Knoxville, Tennessee, United States

Mobile, Alabama, United States

Nashville, Tennessee, United States

Bridgeton, Missouri, United States

Flemington, New Jersey, United States

Tampa, Florida, United States

Edgewood, Kentucky, United States

Mobile, Alabama, United States

Richmond, Virginia, United States

San Diego, California, United States

West Des Moines, Iowa, United States

Huntington Park, California, United States

Tarzana, California, United States

Patients applied

0 patients applied

Trial Officials

Todd Villines, MD

Principal Investigator

University of Virginia

Maros Ferencik, MD

Principal Investigator

Oregon Health and Science University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported