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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06713239
• Lead Sponsor: Cleerly, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Study Start: 2024-12-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.	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: 4. Freedom from PCI without finding of clinically significant stenosis

Secondary Outcome Measures

Name	Time	Method
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	The secondary endpoints assess angina symptoms, medication adherence, and quality of life.; 3. Quality of life assessed using the 20-item Short Form Survey (SF-20).

Trial Locations

Locations (10)

Cardiology of Mobile, Inc.; 🇺🇸 Mobile, Alabama, United States

The University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Cardiology Associates of Mobile; 🇺🇸 Mobile, Alabama, United States

Valiance Clinical Research- Huntington Park; 🇺🇸 Huntington Park, California, United States

Cardiovascular Institute of San Diego; 🇺🇸 San Diego, California, United States

MercyOne Des Moines Medical Center; 🇺🇸 West Des Moines, Iowa, United States

Advanced Heart and Vascular Institute of Hunterdon; 🇺🇸 Flemington, New Jersey, United States

Capital Cardiology Associates; 🇺🇸 Albany, New York, United States

Tristar Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

Chippenham and Johnston Willis Hospitals; 🇺🇸 Richmond, Virginia, United States