NCT06713239

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

Active, Not Recruiting
NAAges 18+InterventionalDiagnostic
Cleerly, Inc.
~1,000 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Cleerly Labs and Cleerly ISCHEMIA

At a glance

Recruiting sites
0 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
Measured over Through study completion- an average of 1 year
+3 more outcomes measured
Coronary Artery Disease
21 sites across 17 states
California4
Florida2
Alabama1
Colorado1
Illinois1
Iowa1
Kentucky1
Louisiana1
  • Todd Villines, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
  • Maros Ferencik, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

\> 18 years
Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)

Exclusion

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
  • The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.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

  • The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.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

  • The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.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

  • The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.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