A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD
PARAMOUNT
1 other identifier
interventional
1,000
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Dec 2024
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2024
CompletedFirst Posted
Study publicly available on registry
December 3, 2024
CompletedStudy Start
First participant enrolled
December 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
March 18, 2026
March 1, 2026
1.8 years
November 27, 2024
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 1\. Improved diagnostic certainty of CAD
Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 2\. Reduction in LDL
Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 3\. Freedom from ICA without a finding of obstructive CAD
Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
The primary endpoint is composed of multuple elements, which are to be compared between Coronary Plaque-Based care and the usual care arm, in a hierarchical fashion, using the win ratio approach: 4\. Freedom from PCI without finding of clinically significant stenosis
Through study completion- an average of 1 year
Secondary Outcomes (3)
The secondary objective of the study is to determine whether a management strategy improves patients' experience of chest pain, quality of life, and adherence to medication.
Through study completion- an average of 1 year
The secondary objective of the study is to determine whether a management strategy improves patients' experience of chest pain, quality of life, and adherence to medication.
Through study completion- an average of 1 year
The secondary objective of the study is to determine whether a management strategy improves patients' experience of chest pain, quality of life, and adherence to medication.
Through study completion- an average of 1 year
Study Arms (2)
Coronary Plaque-Based Care
EXPERIMENTALPatients randomized to the Coronary Plaque-Based Care arm will undergo CCTA with AI-enabled quantitative assessment of the morphology and composition of coronary atherosclerotic plaque and will receive medical and interventional management informed by CCTA findings and per discretion of the treating physician. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days.
Usual Care
NO INTERVENTIONPatients randomized to the Usual Care arm will be referred to their usual care providers for standard of care management post stress test findings, possibly including coronary angiography and/or revascularization per the treating provider's recommendation. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cleerly, Inc.lead
Study Sites (21)
Cardiology Associates of Mobile
Mobile, Alabama, 36608, United States
Valiance Clinical Research- Huntington Park
Huntington Park, California, 90255, United States
Cardiovascular Institute of San Diego
San Diego, California, 91911, United States
Valiance Clinical Research- Tarzana
Tarzana, California, 91356, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Intermountain Health Saint Joseph Hospital
Broomfield, Colorado, 80021, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614, United States
Flourish Research
Winter Park, Florida, 32789, United States
Endeavor Health Clinical Operations
Evanston, Illinois, 60201, United States
MercyOne Des Moines Medical Center
West Des Moines, Iowa, 50266, United States
Saint Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Flourish- Bowie
Bowie, Maryland, 20715, United States
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044, United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
University of Cincinnatti
Cincinnati, Ohio, 45221, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Medical City Fort Worth Hospital
Fort Worth, Texas, 76104, United States
Chippenham and Johnston Willis Hospitals
Richmond, Virginia, 23225, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Villines, MD
University of Virginia
- PRINCIPAL INVESTIGATOR
Maros Ferencik, MD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2024
First Posted
December 3, 2024
Study Start
December 18, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03