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

Cleerly

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Cleerly Labs and Cleerly ISCHEMIA

Study type: Interventional

Funder types: Industry

Identifiers

NCT06713239

Pro00082528

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Coronary Plaque-Based Care

Experimental group

Description:

Patients randomized to the Coronary Plaque-Based Care arm will undergo CCTA with AI-enabled quantitative assessment of the morphology and composition of coronary atherosclerotic plaque and will receive medical and interventional management informed by CCTA findings and per discretion of the treating physician. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days.

Treatment:

Device: Cleerly Labs and Cleerly ISCHEMIA

Usual Care

No Intervention group

Description:

Patients randomized to the Usual Care arm will be referred to their usual care providers for standard of care management post stress test findings, possibly including coronary angiography and/or revascularization per the treating provider's recommendation. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days.