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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Plaque-Based Care | Experimental | Patients randomized to the Coronary Plaque-Based Care arm will undergo CCTA with AI-enabled quantitative assessment of the morphology and composition of coronary atherosclerotic plaque and will receive medical and interventional management informed by CCTA findings and per discretion of the treating physician. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days. |
|
| Usual Care | No Intervention | Patients randomized to the Usual Care arm will be referred to their usual care providers for standard of care management post stress test findings, possibly including coronary angiography and/or revascularization per the treating provider's recommendation. All patients will receive a standardized assessment of clinical and risk factor status at baseline and 180 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleerly Labs and Cleerly ISCHEMIA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | Through study completion- an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion- an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Villines, MD | University of Virginia | Principal Investigator |
| Maros Ferencik, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Associates of Mobile | Mobile | Alabama | 36608 | United States | ||
| Valiance Clinical Research- Huntington Park |
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Prospective, randomized, open-label trial
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| 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). | 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). | Through study completion- an average of 1 year |
| Huntington Park |
| California |
| 90255 |
| United States |
| Cardiovascular Institute of San Diego | San Diego | California | 91911 | United States |
| Valiance Clinical Research- Tarzana | Tarzana | California | 91356 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Intermountain Health Saint Joseph Hospital | Broomfield | Colorado | 80021 | United States |
| Tampa Cardiovascular Interventions and Research | Tampa | Florida | 33614 | United States |
| Flourish Research | Winter Park | Florida | 32789 | United States |
| Endeavor Health Clinical Operations | Evanston | Illinois | 60201 | United States |
| MercyOne Des Moines Medical Center | West Des Moines | Iowa | 50266 | United States |
| Saint Elizabeth Medical Center | Edgewood | Kentucky | 41017 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Flourish- Bowie | Bowie | Maryland | 20715 | United States |
| St. Louis Heart and Vascular | Bridgeton | Missouri | 63044 | United States |
| Advanced Heart and Vascular Institute of Hunterdon | Flemington | New Jersey | 08822 | United States |
| Capital Cardiology Associates | Albany | New York | 12211 | United States |
| University of Cincinnatti | Cincinnati | Ohio | 45221 | United States |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| The University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Medical City Fort Worth Hospital | Fort Worth | Texas | 76104 | United States |
| Chippenham and Johnston Willis Hospitals | Richmond | Virginia | 23225 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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