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AI-enabled quantitative software

Personalized Therapy Management for Coronary Artery Disease (PARAMOUNT Trial)

N/A

Waitlist Available

Led By Maros Ferencik, MD

Research Sponsored by Cleerly, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be over 18 years old

Be older than 18 years old

Must not have

Contraindications to CCTA

Suspected acute coronary syndrome or otherwise unstable clinical status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion- an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using a personalized approach with AI technology to assess plaque in the coronary arteries can improve the diagnosis and management of coronary artery disease compared to the current standard care guidelines.

Who is the study for?

This trial is for people with symptoms suggesting they might have coronary artery disease (CAD). They should be candidates for a CT scan to check their heart arteries. The study excludes those who can't undergo CT scans, are pregnant, or have other serious health issues that could interfere with the trial.

What is being tested?

The PARAMOUNT trial is testing if using AI software to analyze CT images of heart arteries can better manage CAD compared to usual care based on AHA/ACC guidelines. It looks at diagnosis certainty, risk factor control, and efficient use of invasive procedures.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, side effects may include discomfort from the CT scan process or reactions related to contrast agents used in imaging like allergic reactions or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo CCTA due to health reasons.

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I might be having a heart attack or my heart condition is unstable.

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I have a history of serious heart artery blockage.

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My heart's pumping ability is reduced, or I have a serious heart valve problem.

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I have had heart artery testing within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion- an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion- an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion- an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary objective of this study is to determine whether a management strategy improves efficiency and effectiveness.

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Coronary Plaque-Based CareExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 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.

0 / 6Eligibility criteria met