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
Cleerly, Inc.
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
- Age range
- 18+ years
- Sex
- All
- 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)…
Interventions
- DeviceCleerly Labs and Cleerly ISCHEMIA
Participants in the coronary plaque-based care arm will have CCTA at baseline. CCTA images will be redacted and uploaded to Cleerly, interpreted using Cleerly Labs and Cleerly ISCHEMIA, and archived.
Locations (21)
- Cardiology Associates of MobileMobile, Alabama
- Valiance Clinical Research- Huntington ParkHuntington Park, California
- Cardiovascular Institute of San DiegoSan Diego, California
- Valiance Clinical Research- TarzanaTarzana, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, California
- Intermountain Health Saint Joseph HospitalBroomfield, Colorado