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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
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.
Cardiology Associates of Mobile
Mobile, Alabama, United States
RECRUITINGValiance Clinical Research- Huntington Park
Huntington Park, California, United States
RECRUITINGCardiovascular Institute of San Diego
San Diego, California, United States
RECRUITINGValiance Clinical Research- Tarzana
Tarzana, California, United States
RECRUITINGLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
RECRUITINGIntermountain Health Saint Joseph Hospital
Broomfield, Colorado, United States
RECRUITINGTampa Cardiovascular Interventions and Research
Tampa, Florida, United States
RECRUITINGFlourish Research
Winter Park, Florida, United States
RECRUITINGEndeavor Health Clinical Operations
Evanston, Illinois, United States
RECRUITINGMercyOne Des Moines Medical Center
West Des Moines, Iowa, United States
RECRUITING...and 11 more locations
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
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
Time frame: Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
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
Time frame: Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
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
Time frame: Through study completion- an average of 1 year
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
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
Time frame: Through study completion- an average of 1 year
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.
The secondary endpoints assess angina symptoms, medication adherence, and quality of life. 1\. Change in angina symptoms assessed using the Seattle Angina Questionnaire.
Time frame: Through study completion- an average of 1 year
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.
The secondary endpoints assess angina symptoms, medication adherence, and quality of life. 2\. Medication adherence assessed using the Voils DOSE-Nonadherence measure (Blalock, et al. 2019).
Time frame: Through study completion- an average of 1 year
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.
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).
Time frame: Through study completion- an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.