Active, Not Recruiting
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
Led by Cleerly, Inc. · Updated on 2026-06-05
1000
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- > 18 years
- Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)
You will not qualify if you...
- 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
Trial Site Locations
Total: 21 locations
1
Cardiology Associates of Mobile
Mobile, Alabama, United States, 36608
Status Unknown
2
Valiance Clinical Research- Huntington Park
Huntington Park, California, United States, 90255
Status Unknown
3
Cardiovascular Institute of San Diego
San Diego, California, United States, 91911
Status Unknown
4
Valiance Clinical Research- Tarzana
Tarzana, California, United States, 91356
Status Unknown
5
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Status Unknown
6
Intermountain Health Saint Joseph Hospital
Broomfield, Colorado, United States, 80021
Status Unknown
7
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States, 33614
Status Unknown
8
Flourish Research
Winter Park, Florida, United States, 32789
Status Unknown
9
Endeavor Health Clinical Operations
Evanston, Illinois, United States, 60201
Status Unknown
10
MercyOne Des Moines Medical Center
West Des Moines, Iowa, United States, 50266
Status Unknown
11
Saint Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Status Unknown
12
Tulane University
New Orleans, Louisiana, United States, 70112
Status Unknown
13
Flourish- Bowie
Bowie, Maryland, United States, 20715
Status Unknown
14
St. Louis Heart and Vascular
Bridgeton, Missouri, United States, 63044
Status Unknown
15
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, United States, 08822
Status Unknown
16
Capital Cardiology Associates
Albany, New York, United States, 12211
Status Unknown
17
University of Cincinnatti
Cincinnati, Ohio, United States, 45221
Status Unknown
18
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
Status Unknown
19
The University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Status Unknown
20
Medical City Fort Worth Hospital
Fort Worth, Texas, United States, 76104
Status Unknown
21
Chippenham and Johnston Willis Hospitals
Richmond, Virginia, United States, 23225
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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