Coronary Artery DiseasePARAMOUNTNCT06713239
A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD
A study testing Cleerly Labs and Cleerly ISCHEMIA in people with Coronary Artery Disease, run by Cleerly, Inc. at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cleerly Labs and Cleerly ISCHEMIA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 21 sitesUnited States
- Study dates
- 18 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Capital Cardiology Associates
Albany, New York, 12211
Flourish- Bowie
Bowie, Maryland, 20715
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044
Intermountain Health Saint Joseph Hospital
Broomfield, Colorado, 80021
University of Cincinnatti
Cincinnati, Ohio, 45221
Saint Elizabeth Medical Center
Edgewood, Kentucky, 41017
Endeavor Health Clinical Operations
Evanston, Illinois, 60201
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822
Medical City Fort Worth Hospital
Fort Worth, Texas, 76104
Valiance Clinical Research- Huntington Park
Huntington Park, California, 90255
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Cardiology Associates of Mobile
Mobile, Alabama, 36608
Tulane University
New Orleans, Louisiana, 70112
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Chippenham and Johnston Willis Hospitals
Richmond, Virginia, 23225
Cardiovascular Institute of San Diego
San Diego, California, 91911
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614
Valiance Clinical Research- Tarzana
Tarzana, California, 91356
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
MercyOne Des Moines Medical Center
West Des Moines, Iowa, 50266
Flourish Research
Winter Park, Florida, 32789
About this study
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
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cleerly Labs and Cleerly ISCHEMIA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleerly Labs and Cleerly ISCHEMIADevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cleerly Labs and Cleerly ISCHEMIA |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Improved diagnostic certainty of CAD
Measured: 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:
- Reduction in LDL
Measured: 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:
- Freedom from ICA without a finding of obstructive CAD
Measured: 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:
- Freedom from PCI without finding of clinically significant stenosis
Measured: Through study completion- an average of 1 year
Secondary outcomes (3)
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.
- Change in angina symptoms assessed using the Seattle Angina Questionnaire.
Measured: 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.
- Medication adherence assessed using the Voils DOSE-Nonadherence measure (Blalock, et al. 2019).
Measured: 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.
- Quality of life assessed using the 20-item Short Form Survey (SF-20).
Measured: Through study completion- an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start18 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleerly, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Villines, MD, Principal investigator, University of VirginiaMaros Ferencik, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713239
- Sponsor's protocol ID
- Pro00082528
- Acronym
- PARAMOUNT
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06713239
- Acronym / sponsor ID
- PARAMOUNT / Pro00082528
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cleerly, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label trial
| Arm | Type | Receives |
|---|---|---|
| Coronary Plaque-Based Care | Experimental | Device: Cleerly Labs and Cleerly ISCHEMIAPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years
- Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleerly Labs and Cleerly ISCHEMIAParticipants 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. | Device | Coronary Plaque-Based Care |
Primary outcome
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
3 secondary outcomes
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.
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.
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.
Time frame: Through study completion- an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Villines, MD principal investigator
University of Virginia
Maros Ferencik, MD principal investigator
Oregon Health and Science University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleerly Labs and Cleerly ISCHEMIA in people with Coronary Artery Disease, run by Cleerly, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness. (time frame: Through study completion- an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.