Clinical trial NCT06713239: A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Cleerly, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open-label trial
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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 outcomes:
measure: The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
timeFrame: Through study completion- an average of 1 year
measure: The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
timeFrame: Through study completion- an average of 1 year
measure: The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
timeFrame: Through study completion- an average of 1 year
measure: The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
timeFrame: Through study completion- an average of 1 year
Secondary outcomes:
measure: 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.
timeFrame: Through study completion- an average of 1 year
measure: 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.
timeFrame: Through study completion- an average of 1 year
measure: 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.
timeFrame: Through study completion- an average of 1 year
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Huntington Park
country: United States
facility: Valiance Clinical Research- Huntington Park
state: California
city: San Diego
country: United States
facility: Cardiovascular Institute of San Diego
state: California
city: Tarzana
country: United States
facility: Valiance Clinical Research- Tarzana
state: California
city: Tampa
country: United States
facility: Tampa Cardiovascular Interventions and Research
state: Florida
city: West Des Moines
country: United States
facility: MercyOne Des Moines Medical Center
state: Iowa
city: Bridgeton
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Flemington
country: United States
facility: Advanced Heart and Vascular Institute of Hunterdon
state: New Jersey
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center
state: Tennessee
city: Richmond
country: United States
facility: Chippenham and Johnston Willis Hospitals
state: Virginia
Study officials:
affiliation: University of Virginia
name: Todd Villines, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Maros Ferencik, MD
role: PRINCIPAL_INVESTIGATOR
References: