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

NCT06713239 · tracked via the Priya Life Science USA tracker

Sponsor

Cleerly, Inc.

Phase

Not applicable

Started

2024-12-18

Last updated

2026-06-05

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Cleerly Labs and Cleerly ISCHEMIA

Cleerly 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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: 1\. Improved diagnostic certainty of CAD
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: 2\. Reduction in LDL
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: 3\. Freedom from ICA without a finding of obstructive CAD
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

Trial sites (21)

Facility	City	Region
Cardiology Associates of Mobile	Mobile	Alabama
Valiance Clinical Research- Huntington Park	Huntington Park	California
Cardiovascular Institute of San Diego	San Diego	California
Valiance Clinical Research- Tarzana	Tarzana	California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
Intermountain Health Saint Joseph Hospital	Broomfield	Colorado
Tampa Cardiovascular Interventions and Research	Tampa	Florida
Flourish Research	Winter Park	Florida
Endeavor Health Clinical Operations	Evanston	Illinois
MercyOne Des Moines Medical Center	West Des Moines	Iowa
Saint Elizabeth Medical Center	Edgewood	Kentucky
Tulane University	New Orleans	Louisiana
Flourish- Bowie	Bowie	Maryland
St. Louis Heart and Vascular	Bridgeton	Missouri
Advanced Heart and Vascular Institute of Hunterdon	Flemington	New Jersey
Capital Cardiology Associates	Albany	New York
University of Cincinnatti	Cincinnati	Ohio
Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
The University of Tennessee Medical Center	Knoxville	Tennessee
Medical City Fort Worth Hospital	Fort Worth	Texas
Chippenham and Johnston Willis Hospitals	Richmond	Virginia

More Cleerly, Inc. trials in the USA

Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry Enrolling by invitation

A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events Recruiting

Other trials for the same condition

AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management Active, not recruiting

Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry Enrolling by invitation

Prevail Global Study Recruiting

Firehawk Rapamycin Target Eluting Coronary Stent North American Trial Active, not recruiting

Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06713239 on ClinicalTrials.gov ↗ ← All trials in the USA