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

March 16, 2026 updated by: Cleerly, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Cardiology Associates of Mobile
        • Contact:
          • Jason Cole, MD
    • California
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Valiance Clinical Research- Huntington Park
        • Contact:
          • Amir Rafie, MD
      • San Diego, California, United States, 91911
        • Recruiting
        • Cardiovascular Institute of San Diego
        • Contact:
          • Milind Parikh, MD
      • Tarzana, California, United States, 91356
        • Recruiting
        • Valiance Clinical Research- Tarzana
        • Contact:
          • Aamer Jamali, MD
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Contact:
          • Suvasini Lakshmanan, MD
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • Recruiting
        • Intermountain Health Saint Joseph Hospital
        • Contact:
          • Christopher Angus, MD
    • Florida
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Tampa Cardiovascular Interventions and Research
        • Contact:
          • Saihari Sadanandan, MD
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Flourish Research
        • Contact:
          • Monica Aggarwal, MD
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health Clinical Operations
        • Contact:
          • Amit Pursnani, MD
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • MercyOne Des Moines Medical Center
        • Contact:
          • Enrico Martin, MD
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Medical Center
        • Contact:
          • Travis Huffman, DO
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University
        • Contact:
          • Robert Hendel, MD
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish- Bowie
        • Contact:
          • Sara Collins, MD
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Recruiting
        • St. Louis Heart and Vascular
        • Contact:
          • Gil Vardi, MD
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Recruiting
        • Advanced Heart and Vascular Institute of Hunterdon
        • Contact:
          • Andrey Espinoza, MD
    • New York
      • Albany, New York, United States, 12211
        • Recruiting
        • Capital Cardiology Associates
        • Contact:
          • Augustin DeLago, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • Recruiting
        • University of Cincinnatti
        • Contact:
          • Donald Wayne, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Cardiovascular Research Group
        • Contact:
          • Mazen Abu-Fadel, MD
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • The University of Tennessee Medical Center
        • Contact:
          • Kashif Shaikh, MD
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Medical City Fort Worth Hospital
        • Contact:
          • Giri Mundluru, MD
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • Chippenham and Johnston Willis Hospitals
        • Contact:
          • Nayef Abouzaki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coronary Plaque-Based Care
Patients 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.
Device: 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.
No Intervention: Usual Care
Patients 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
Time Frame: Through study completion- an average of 1 year

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.
Time Frame: Through study completion- an average of 1 year

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.
Time Frame: Through study completion- an average of 1 year

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.
Time Frame: Through study completion- an average of 1 year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion- an average of 1 year

The secondary endpoints assess angina symptoms, medication adherence, and quality of life.

1. Change in angina symptoms assessed using the Seattle Angina Questionnaire.
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.
Time Frame: Through study completion- an average of 1 year

The secondary endpoints assess angina symptoms, medication adherence, and quality of life.

2. Medication adherence assessed using the Voils DOSE-Nonadherence measure (Blalock, et al. 2019).
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.
Time Frame: Through study completion- an average of 1 year

The secondary endpoints assess angina symptoms, medication adherence, and quality of life.

3. Quality of life assessed using the 20-item Short Form Survey (SF-20).
Through study completion- an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleerly, Inc.

Investigators

  • Principal Investigator: Todd Villines, MD, University of Virginia
  • Principal Investigator: Maros Ferencik, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00082528

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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