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

Running, not enrolling · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06713239

Run by

Cleerly, Inc.

People needed

1000

Starts

2024-12-18

Expected to finish

2026-12-01

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 18 years
• Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)

You may not qualify if…

• 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 it is running

• 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

Full record on ClinicalTrials.gov

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