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NCT Number: NCT06713239

A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Associates of Mobile, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cleerly Labs and Cleerly ISCHEMIA

Device

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.

Primary outcomes

  1. 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:

    • Improved diagnostic certainty of CAD

  2. 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:

    • Reduction in LDL

  3. 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:

    • Freedom from ICA without a finding of obstructive CAD

  4. 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:

    • Freedom from PCI without finding of clinically significant stenosis

Secondary outcomes

  1. 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.

    • Change in angina symptoms assessed using the Seattle Angina Questionnaire.

  2. 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.

    • Medication adherence assessed using the Voils DOSE-Nonadherence measure (Blalock, et al. 2019).

  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.

    Time frame: Through study completion- an average of 1 year

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

    • Quality of life assessed using the 20-item Short Form Survey (SF-20).

Sponsors and collaborators

Lead sponsor

Cleerly, Inc.

Industry

Registry information

Official study title

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

Acronym: PARAMOUNT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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