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Personalized Therapy Mgmt vs. Usual Care

Sponsor:

Cleerly, Inc.

Code:

NCT06713239

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cleerly Labs and Cleerly ISCHEMIA

Study Details

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.

Conditions

Coronary Artery Disease

Study ID

NCT06713239

Start date

Dec 18, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Coronary Plaque-Based Care

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.

no intervention: Usual Care

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.

Interventions

Cleerly 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.

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 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 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 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 ]

Central Contacts and Locations

More Information

Sponsor

Cleerly, Inc.

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Cleerly, Inc. on 2026-06-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.