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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
Sponsor: Cleerly, Inc.
Summary
PARAMOUNT is a prospective randomized open-label trial testing the hypothesis that a personalized management strategy in symptomatic patients with suspicion of coronary artery disease (CAD), using a CT-based coronary atherosclerotic plaque assessment by AI-enabled quantitative software improves: certainty for diagnosis of CAD, control of CAD risk factors and efficiency of ICA referral with appropriate PCI compared to the usual care strategy based on current AHA/ACC guidelines for care of symptomatic patients with suspicion of CAD.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2024-12-18
Completion Date
2026-10
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Cleerly Labs and Cleerly ISCHEMIA
Participants in the coronary plaque-based care arm will have CCTA at baseline. CCTA images will be redacted and uploaded to Cleerly, interpreted using Cleerly Labs and Cleerly ISCHEMIA, and archived.
Locations (21)
Cardiology Associates of Mobile
Mobile, Alabama, United States
Valiance Clinical Research- Huntington Park
Huntington Park, California, United States
Cardiovascular Institute of San Diego
San Diego, California, United States
Valiance Clinical Research- Tarzana
Tarzana, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Intermountain Health Saint Joseph Hospital
Broomfield, Colorado, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States
Flourish Research
Winter Park, Florida, United States
Endeavor Health Clinical Operations
Evanston, Illinois, United States
MercyOne Des Moines Medical Center
West Des Moines, Iowa, United States
Saint Elizabeth Medical Center
Edgewood, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
Flourish- Bowie
Bowie, Maryland, United States
St. Louis Heart and Vascular
Bridgeton, Missouri, United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, United States
Capital Cardiology Associates
Albany, New York, United States
University of Cincinnatti
Cincinnati, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, United States
Medical City Fort Worth Hospital
Fort Worth, Texas, United States
Chippenham and Johnston Willis Hospitals
Richmond, Virginia, United States