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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Cleerly, Inc.
- Enrollment
- 1,000
- Locations
- 41
- Primary Endpoint
- The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care
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.
Coronary Plaque-Based Care
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.
Intervention: Cleerly Labs and Cleerly ISCHEMIA (Device)
Outcomes
Primary Outcomes
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: 1\. Improved diagnostic certainty of CAD
Secondary Outcomes
- 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.(Through study completion- an average of 1 year)