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

Last updated: August 22, 2025
Sponsor: Cleerly, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Heart Disease

Coronary Artery Disease

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

    Site Not Available

  • Cardiology of Mobile, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Cardiology Associates of Mobile

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Valiance Clinical Research- Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Cardiovascular Institute of San Diego

    San Diego, California 91911
    United States

    Site Not Available

  • Valiance Clinical Research- Tarzana

    Tarzana, California 91356
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Valiance Clinical Research- Huntington Park

    Huntington Park 5358736, California 5332921 90255
    United States

    Active - Recruiting

  • Cardiovascular Institute of San Diego

    San Diego 5391811, California 5332921 91911
    United States

    Active - Recruiting

  • Valiance Clinical Research- Tarzana

    Tarzana 5401143, California 5332921 91356
    United States

    Active - Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance 5403022, California 5332921 90502
    United States

    Active - Recruiting

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • Flourish Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Tampa Cardiovascular Interventions and Research

    Tampa 4174757, Florida 4155751 33614
    United States

    Active - Recruiting

  • Flourish Research

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • MercyOne Des Moines Medical Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • MercyOne Des Moines Medical Center

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Active - Recruiting

  • Saint Elizabeth Medical Center

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Saint Elizabeth Medical Center

    Edgewood 4290873, Kentucky 6254925 41017
    United States

    Active - Recruiting

  • Tulane University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane University

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Active - Recruiting

  • Flourish- Bowie

    Bowie, Maryland 20715
    United States

    Site Not Available

  • Flourish- Bowie

    Bowie 4349159, Maryland 4361885 20715
    United States

    Active - Recruiting

  • St. Louis Heart and Vascular

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • St. Louis Heart and Vascular

    Bridgeton 4378391, Missouri 4398678 63044
    United States

    Active - Recruiting

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey 08822
    United States

    Site Not Available

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington 5098124, New Jersey 5101760 08822
    United States

    Active - Recruiting

  • Capital Cardiology Associates

    Albany, New York 12211
    United States

    Site Not Available

  • Capital Cardiology Associates

    Albany 5106834, New York 5128638 12211
    United States

    Active - Recruiting

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oklahoma Cardiovascular Research Group

    Oklahoma City 4544349, Oklahoma 4544379 73120
    United States

    Active - Recruiting

  • The University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Tristar Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • The University of Tennessee Medical Center

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Active - Recruiting

  • Medical City Fort Worth Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Medical City Fort Worth Hospital

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Active - Recruiting

  • Chippenham and Johnston Willis Hospitals

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Chippenham and Johnston Willis Hospitals

    Richmond 4781708, Virginia 6254928 23225
    United States

    Active - Recruiting

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