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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \> 18 years
• Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)
Locations
United States
Alabama
Cardiology Associates of Mobile
RECRUITING
Mobile
California
Valiance Clinical Research- Huntington Park
RECRUITING
Huntington Park
Cardiovascular Institute of San Diego
RECRUITING
San Diego
Valiance Clinical Research- Tarzana
RECRUITING
Tarzana
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING
Torrance
Colorado
Intermountain Health Saint Joseph Hospital
RECRUITING
Broomfield
Florida
Tampa Cardiovascular Interventions and Research
RECRUITING
Tampa
Flourish Research
RECRUITING
Winter Park
Iowa
MercyOne Des Moines Medical Center
RECRUITING
West Des Moines
Illinois
Endeavor Health Clinical Operations
RECRUITING
Evanston
Kentucky
Saint Elizabeth Medical Center
RECRUITING
Edgewood
Louisiana
Tulane University
RECRUITING
New Orleans
Maryland
Flourish- Bowie
RECRUITING
Bowie
Missouri
St. Louis Heart and Vascular
RECRUITING
Bridgeton
New Jersey
Advanced Heart and Vascular Institute of Hunterdon
RECRUITING
Flemington
New York
Capital Cardiology Associates
RECRUITING
Albany
Ohio
University of Cincinnatti
RECRUITING
Cincinnati
Oklahoma
Oklahoma Cardiovascular Research Group
RECRUITING
Oklahoma City
Tennessee
The University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
Medical City Fort Worth Hospital
RECRUITING
Fort Worth
Virginia
Chippenham and Johnston Willis Hospitals
RECRUITING
Richmond
Contact Information
Primary
Ryann Sardinia
ryann.sardinia@cleerlyhealth.com
7207398191
Backup
Vidhya Kumar
vidhya.kumar@cleerlyhealth.com
7207398191
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1000
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Cleerly, Inc.