Coronary Artery Disease
Conditions
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.
Interventions
DEVICECleerly 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.
Sponsors
Cleerly, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, randomized, open-label trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. 1\. Change in angina symptoms assessed using the Seattle Angina Questionnaire. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTodd Villines, MD
University of Virginia
PRINCIPAL_INVESTIGATORMaros Ferencik, MD
Oregon Health and Science University
Outcome results
None listed