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

Last updated: April 30, 2025
Sponsor: Cleerly, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Hypercholesterolemia

Chest Pain

Treatment

Cleerly Labs and Cleerly ISCHEMIA

Clinical Study ID

NCT06713239
Pro00082528
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • > 18 years

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

Exclusion

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 coronaryangiography (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 Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Cleerly Labs and Cleerly ISCHEMIA
Phase:
Study Start date:
December 18, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Cardiology Associates of Mobile

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Cardiology of Mobile, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Cardiovascular Institute of San Diego

    San Diego, California 91911
    United States

    Active - Recruiting

  • MercyOne Des Moines Medical Center

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey 08822
    United States

    Active - Recruiting

  • Tristar Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Chippenham and Johnston Willis Hospitals

    Richmond, Virginia 23225
    United States

    Active - Recruiting

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