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

a study on Coronary Artery Disease Peripheral Artery Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
study ends around

Description

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.

Official 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

Keywords

Coronary Artery Disease, Atherosclerotic Plaque, Cleerly Labs and Cleerly ISCHEMIA

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Valiance Clinical Research- Tarzana accepting new patients
    Tarzana California 91356 United States
  • Valiance Clinical Research- Huntington Park accepting new patients
    Huntington Park California 90255 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cleerly, Inc.
ID
NCT06713239
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated