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

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

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

Conditions2

Locations21 sites

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